Mike Salehi **** Lonesome Spur Trl, McKinney, Texas 75070

Cell phone #: 469-***-**** E-mail: adl8i2@r.postjobfree.com

SUMMARY OF EXPERIENCE

Medical Device, Aerospace, Military products ISO 9001/9100, 13485, 14971, QSR 21 CFR 820, AS9100

CAPA, FMEA, Control Plan, Manufacturing Health & Hazard Evaluation, Risk Assessment

Design & Clinical Risk Management (DCRM) Risk Management Process, Procedure

Document Control, Validation, Verification Corrective and Preventive Action (CAPA)

DHF review and verification, Gap Analysis DHF/510k/ Design Control, investigation, remediation

New Product Development (NPD) Manufacturing, Production Process flow, Production

MRB team member, Disposition of product PFMEA, SOP and Procedure

Continuous Improvement, Documentation Daily support of manufacturing, operations/Assembly line

Root cause investigation, CAR Customer Complaints evaluation and review

Create/update SOP/W.I. & procedures Resolve QA issues at Customer and Supplier level

Document Change Order (DCO), Deviation Engineering Change notice (ECN), E.C. Orders (ECO)

8D (8-Step Corrective Actions Report), A3 Review/Approved non-conforming materials – Patience Complaints.

Good Documentation Practices (GDP) Determine proper corrective/preventative action.

Good Manufacturing Practices (cGMP) International and domestic supplier and internal audit

Root cause investigation, CAR Supplier Corrective Action Request (SCAR)/

Military Standard MIL-883, MIL-PRF38535 Review Customer and Supplier Document

Experience in Remediation of QMS, Tech File, DHF

QRQC tool (Quick Response Quality Control)

EDUCATION

Bachelor of Science (B.S.) degree in Electrical Engineering - Bluefield State College, Bluefield, WV

Associate of Science (A.S.) degree in Mechanical Engineering - Bluefield State College, Bluefield, WV

Professional Experience

Sr. Program Quality Engineer April 2018 - March 2021

Cobham Mission System, - Defense and Aerospace / Medical Oxygen System - Davenport, Iowa

Member of Integrated Product Teams (IPTs) for new programs, participating from initial lifecycle phases through transition to production.

Serve as the Sr. Program Quality Engineer Representative for six programs/Projects: PBG Tester (DHF248), GGU-25/A (DHF314), CRU-123 (DHF353), Parker A321XLR (DHF365), & FTIS O2 Sensor (DHF375)

Directly involved with Engineering team, Manufacturing, and Quality for new Products Support, Bid/Design/Developmental Activities.

Supported and coordinated new product Design History Files.(e.g., TBR, SRR, SDR, PDR, CDR, TRR, & PRR).

Quality Representative for approval of ECNs, Creating and disposition of nonconforming products, investigate causes of NC for returned products and make recommendations for all my programs responsibility.

Interpret engineering drawings and specifications, customer quality requirements, and internal quality requirements to ensure compliance with the customer's expectations and internal processes and procedures.

Manage customer and internal communication in a timely and professional manner ensure they handled as required.

Coordinate and Liaison between cross-functional team to solve customer/Supplier quality requirements and issues.

Ensures new product development compliance to ISO9100 and any other applicable standards.

Provide support, problem solving for product development, and manufacturing.

Perform Root Cause Corrective Action utilizing disciplined methodologies such as 8D/A3 to ensure effectiveness.

Participate in Phase and Design Reviews and assist in the review and approval of quality documents such as work Instruction, Procedure, and reports.

Maintain full compliance and conducts all activities in accordance with Company policies and procedures.

Advanced Product Quality Planning (APQP) team member.

Worked with buyer/Supply Chain/ and internal receiving and shipping and our third party distribution center group on Non-conformance product.

Report and document concern of quality and/or safety to the management or Safety Engineer, as applicable.

Assist in the preparation, review, and approval (if applicable) of quality documents such as plans, policies, procedures, and reports. Participate in audits when required.

Quality Engineer (Consultant position) July 2017 – Oct 2017

Lonza - Pharma Biotech – Walkersville, MD

Created Design Control (21 CFR 820.30) requirement template checklist for gap assessment. including design input/output, review, verification, validation, transfer, and change. To be sure the design of a medical device is safe, effective and meets the user requirements throughout the device lifecycle.

Per Design Control requirement I created Design History File (DHF) for legacy products and performed Gap analysis to determine what additional tests, documentation, risk management, traceability, verification, and validation needed to close the gaps and provide objective evidence to bring DHF in line with the recently updated quality management system.

Gathered all paper records and collected documentation recorded on disks, included deliverables, artifacts, specification generated during the design and development activity, and any changes made to product and documentation generated the changes, and tests under approved protocol to prove good controls is in place.

Reviewed and gap analysis for legacy product and upgraded the DHF file to bring Legacy products into Compliance with 21 CFR 820.

Performed and reviewed documentation in existing internal Management System database, Quality documentation paper records in Document Control files, and reviewed all SOP, W.I. and Procedure to assess the gap in DHF file.

Performed 510(K) Gap Assessment to identify missing documentation required for legacy products to compliance with regulatory expectations.

Confirmed the DHF consists of a set of documents or records that demonstrates the design is developed in accordance with the Design and Development Plan and describes the design history of a finished medical device.

Recommended per the current Good Manufacturing Practice (cGMP), company continuously update throughout the device lifetime as major changes are introduced.

Recommended to maintain (DHF) file as per the Code of Federal Regulations (CFR) Title 21 Part 820.30.

Quality Engineer (Consultant position) March 2017 – April 2017

Philips – Bothell, WA

•Review, investigate, and verify closed CAPA for company FDA audit. Each product needs to have a gap analysis to determine obsolescence or validate.

•Reviewed checklist to verify all requirement meet the CAPA applicable standards and specification.

•Assist CAPA Owners with the verification, and documentation of Corrective and Preventive Actions to ensure completeness.

•Follow up and assist CAPA owner on all action items until items are effectively completed and closed.

•Support and ensure that corrective and preventive actions issued as required, properly investigated, documented, and completed.

•Reviewed, revised, and improved Problem description, Communication Summary, Risk Summary, Containment Action, Root Cause, CA, PA, Effectiveness Criteria, Implementation Summary, Reinvestigation Notes, Closure Comment, and post closure for CAPA.

•Conduct verification of product and process (CAPA) investigations, from issue identification through implementation of solution and effectiveness monitoring.

•Document all phases of CAPA activity in compliance with applicable standards including 21 CFR part 820.100 and ISO 13485, and procedural requirements.

•Maintain CAPA records, keeping them in a state of audit readiness.

Design Quality Engineer (Consultant position) July 2015 – Dec 2016

DePuy Synthes, companies of Johnson & Johnson – West Chester, PA and Monument, CO

•Design Quality Engineer project team member to support Technical File remediation for Medical Device Directive (MDD; EU Council Directive 93/42/EEC) and CE-Marking.

•Support sustaining engineering on Technical file remediation and review and verified file requirements (e.g., Essential Requirements, Risk analysis, design control, clinical evaluation, test reports) and all supporting information and detail documentation.

•Review and support risk management for Orthopedics Instrumentation to ensure high level of compliance to FDA QSR 21 CFR 820, ISO 13485, and ISO 14971and European standard in all assigned areas.

•Provide input in support of design control activities. Reviewed documents associated with the design and manufacture of products including specifications, testing protocols and reports.

•Review and approve verification/validation test protocols and reports documentation, Risk Management Report (RMR), Risk Management Plane (RMP), Design and Clinical Risk Management (DCRM/DFMEA), Essential Requirements Checklist (ERC), List of Applied Standards (Load), functional assessment (FA), Corrosion Resistance Rational, External Part List (EPL), MDD harmonize Standard list, and Process PFMEA.

•Review and verified all Surgical Technique Guide (STG) precaution, warning, Article lists that references in the documentation for technical file.

•Reviewed, verified Sales and Complaints (S&C) product article list to ensure all parts in scope are analyzed over the correct time.

•Ensure in Risk Management Report (RMR) all AFAP (As Far as Possible)/High risks are adequately addressed from the DCRM and Production Risk Management (PRM/PFMEA) documents.

•Transferred to DePuy Synthes (J&J) at Monument, CO for remediation of supplier Process FMEA (PFMEA).

•Project Team member for remediation of Production Risk Management (PRM/PFMEA) to ensure compliance to FDA QSR 21 CFR 820, ISO 13485, and ISO 14971.

•Create and/or provide support in creation of Risk Management documents

•Interface with Quality Engineer sustaining group, Product Development engineer (PDE), Manufacturer engineer (ME) and different team member to discuss the design output, hazards and hazard situation and cause of manufacturing failure to complete the remediation of Supplier manufacturing (PFMEA).

•Reviewed and created Risk Management documents PRM/PFMEA per ISO 14971 and supplier manufacturing process flow/traveler/router.

•Reviewed supplier manufacturing process flow/traveler/router and worked with suppliers on all quality related issues. Such as hazards and hazard situation, cause of manufacturing failure, current control, and reference for control to complete the Production Risk Management (PRM)/Process FMEA.

•Worked with Windchill (Product Lifecycle Management (PLM) and Agile software to search for documentation and CATSWeb software for Complaint Handling System to identify complaints for US/EU.

•Understand and work with drawings, prints, Inspection Sheet, manufacturing assembly part router, traveler, Packaging, Shipping and Supplier PFMEA/Router of the parts.

Quality Engineer Compliance Specialist (Consultant position) Nov 2014 – Jan 2015

Alcon Laboratories, Inc., (NOVARTIS GROUP COMPANIES) - Fort Worth, Texas

•Review Distribution Center (DC)/Transportation/Customs Compliance documentation to ensure compliance with established quality standards and regulatory requirements.

•Performed and generating Risk Management documents per ISO 14971activity to identify and report related risks for shipping and receiving assembly processes.

•Reviewed yearly approval for current Supplier certification through the documentation audit and questionnaire.

•Identified, implemented and support changes in processes and assembly while continuing to maintain a compliance with the FDA, ISO and regulatory.

•Investigate quality issues and review the results of Distribution investigations. Provides written reports of the findings.

Coordinated internal inspections and compliance audits in conjunction with Standard Operating Procedures (SOPs) and Work Instructions (WIs) and ensures that training of employee is applicable to corporate Quality Assurance.

•Worked with buyer/Supply Chain/ and internal receiving and shipping distribution center group on Non-conformance product.

•Ensures that training of a general and specific nature, applicable to Quality Control in the Distribution organization is enforced.

Design Quality Engineer (Consultant position) May 2013 – October 2014

DePuy Synthes, companies of Johnson & Johnson - West Chester, PA

•Project team member for Global Remediation Quality Plan (GRQP) ensure high level of compliance to FDA QSR 21 CFR 820, ISO 13485, and ISO 14971 in all assigned areas.

•Participated in project teams with Design Quality, regularity, and sustaining engineering to provide Support for Risk Management activities including Design & Clinical risk Management (DCRM/DFMEA).

•Supported sustaining product development engineering teams to ensure Good Documentation Practices (GDP) and compliance to Medical Devices regulation and specification.

•Support risk management and risk analysis including FMEA, PFMEA and DCRM (DFMEA)

•Performed risk management analysis to assist cross functional team in identification of risk for orthopedics Instrumentation and defect, severity, and process control.

•Revised existing Risk Management documents per ISO 14971, SOP, and procedure.

•Reviewed, audit and revised old FMEA format into the new revised Design & Clinical risk Management (DCRM/DFMEA) format, and at the same time identified any gaps or new risk, hazard and hazard situation and harm.

•Ensure all As Far as Possible/High risks are adequately addressed in DCRM/DFMEA and in Risk Management Report (RMR).

•Performed audit/review Design History Files (DHF) Legacy documentation remediation, due to gaps discovered for Class II, Class III Medical Devices.

Worked with Windchill (Product Lifecycle Management (PLM) and Agile software to search for documentation and CATSWeb software for Complaint Handling System to identify complaints for US/EU.

Support Project Manager to tracking all projects and update weekly projects performance for reporting to management.

Attended surgeries labs with DQE, sales, marketing, surgeons to build understanding of user needs and conduct design usability.

Quality Engineer (Consultant position) May 2012 – April 2013

Eaton, Cooper Power Systems Division - Nacogdoches, Texas

•Provided engineering support to improve a total quality system and performing verification and auditing internal department and preparing the manufacturer for an IS0 9001-2008 certification.

•Lead six QC, attended management meeting and managed department in absent of QA manager.

•Lead the investigation, resolution and evaluation of product and process non-conformances and

assisted in the maintenance and continuous improvement of the plant Quality Management processes.

•Participate verification and validation documentation of equipment Insulation Qualification (IQ).

•Performed verification and validation of Operation Qualification (OQ) and Process Qualification (PQ).

•Lead CAPA investigations to adequately identify root cause and implement appropriate corrective and preventative actions to prevent reoccurrence.

•Process non-conformance products reports including MRB dispositioning.

•Responsible for MRB activities for assigned products, timely resolution of nonconformities, issuing and/or monitoring corrective actions associated with nonconformance and deviations.

•Worked with manufacturing to resolve non-conformance issues, using root cause analysis and corrective and preventive actions (CAPA). Support product change order (PCO) process.

•Lead manufacturing Non Conformance product (NCP) not meeting specification and hold for further processing or shipment until non-conformance are resolved.

•Coordinated and ensure training, process, work instruction, calibration, and procedures meets & exceed customer’s quality expectations and compliance with quality policies.

•Support and maintain QRQC (Quick Response Quality Control), 5S/6S, Kaizen, Five whys.

•Interact with internal departments to identify/resolve issues in a timely, cost effective and productive manner.

•Lead audit, NCR. SCAR, and CAPA investigation and field/customer, in-coming/in-process issues.

•Lead investigation in response to Internal Audit, production non-conformance and customer returns.

•Used 8D problem solving for NCs in Q-pulse software to report to customer and management.

•Worked with buyer/Planner/ and internal receiving and shipping distribution center group on Non-conformance product.

•Worked with Q-pulse system software (e.g., Documentation, Internal Audits, Analysis, CAPA, Customer Complaints.

•Reduced customer complaints and return failure warranty tickets from 197 down to 116 CARs, this has drastically reduced average open warranty tickets time open over 40% from 109 to 72 days.

Quality Engineer (Consultant position) June 2010 – Dec 2011

Abbott Laboratories (Formerly St. Jude Medical) - Dallas, Texas

•Performed risk management/assessment activity, Health Hazard Evaluation (HHE), safety hazards investigations, root cause analysis, Customer Compliant evaluation per ISO 13485, ISO 14971and QSR 21 CFR 820.

•Performed evaluation and analyses of complaints to ensure accurate, timely, and regulatory compliant, completion of all tasks related to complaint records from record inception to record closure.

•Performed complaint investigation to determine if they need to be entered into the (CAPA).

•Supported and updated Risk Management profiles and FMEA and FMECA documentation for spinal cord and deep brain stimulation implantable for Eon, Eon C, Eon mini, Genesis products.

•Reviewed complaints documentation for completeness and consistency and executed additional actions as necessary to close or determine appropriate disposition of the complaints file in CATSWeb software. .

•Interact and communicate with internal customers for reporting of complaints and adverse events (this may include intake and/or follow up requests for information).

•Performed complaints evaluation and investigate complaints that require additional review for reporting (e.g., Medical Device Reporting (MDR), (CAPA) or other event reporting. Ensure all potentially reportable complaints are escalated to appropriate levels of management.

Quality Sales Agent E.Z. Ticket Travel Agency, (Family owned Business) Dallas, Texas Feb 2009 – June 2010

•Provided professional and cost effective travel arrangements for clients while providing excellent customer quality service. Worked with a partner travel agency to book airfares.

Supplier Quality Engineer June 2007- Nov 2008

Luminator Technology Group - Dallas, Texas

•Participated in company AS9001 Re-Certification audits.

•Performed internal and external audits as required to ensure process and procedures are being adhered and evaluate supplier internal function to assess supplier overall performance and provide feedback in assessment of their operation.

•Interface with all department including manufacturing, production line, Purchasing, Planning, distribution Center, Marketing, Failure Analysis, offshore manufacturing facilities and engineering in US, Canada, and China. Support product change order (PCO) process.

•Lead and support supplier Performance Reviews and supplier audits for compliance to regulations, agreements, standards, and documented processes.

•Conducted supplier audit and sub-supplier in China for non-conformance to ensure supplier follow all procedure and policy to build quality products and meet quality requirements.

•Lead investigation for field/customer failures, in-coming, in-process, final inspection activities and execute (SCAR/CAPA) process. Review Deviations documentation associated with manufacturing operations.

•Execute and document supplier non-conformance reports (NCRs), Supplier Corrective Action Requests (SCARs) and Corrective and Preventive Actions (CAPAs).

•Responsible for MRB activities for assigned products, timely resolution of nonconformities, issuing and/or monitoring corrective actions associated with nonconformance and deviations.

•Lead in the resolution of non-conformance (NC) product, supplier/customer complaints, and (CA).

•Lead Supplier Corrective Action Request (SCAR) investigations to adequately identify root cause and implement appropriate corrective and preventative actions to prevent reoccurrence.

•Lead SCAR to notify suppliers of quality issues on incoming products or services and for requesting suppliers to take appropriate actions to prevent recurrences.

•Worked with buyer/Supply Chain/ and internal receiving and shipping distribution center group on Non-conformance product.

•Coordinate the design, build and debug of tooling and test equipment and work with engineering to ensure design for Manufacturability.

•Managed effective communication and supported day-to-day offshore manufacturing assembly and engineering operations in China, and Canada. Ensured that all activities carried out in a safe and efficient manner.

•Support verification and validation documentation of equipment Insulation Qualification (IQ), Operation Qualification (OQ) and Process Qualification (PQ).

•Lead Non-Conformity reports (NCR) investigations to identify root causes and issued Supplier Corrective Action Request (SCAR) to ensure effective resolution of quality issues including MRB disposition.

•Lead and maintained Supplier Change Notifications, Deviation, and investigations to meet material requests and process per all applicable procedures and quality requirements.

•Supported quality activities such as root cause analysis, CAPA, risk management, verification & validation.

•Supported manufacturing, production line, troubleshoot defects, and resolved related requirements such as, Printed Circuit Boards (PCB), Cables and outdoor Programmable Digital LED Sign.

•Track supplier quality performance monitored supplier delivery, quality, capacity, and capability.

•Review/Write/Edit, SOP, Procedures, and specification, work instructions, batch records, etc.

Supplier Quality Engineer/QC, MGR Jan 2003 – June 2007

Computer Solution - Dallas, Texas

•Lead Supplier Corrective Action Request (SCAR) investigations to adequately identify root cause and implement appropriate corrective and preventative actions to prevent reoccurrence.

•Lead SCAR to notify suppliers of quality issues on incoming products or services and for requesting suppliers to take appropriate actions to prevent recurrences.

•Lead nonconformity reports (NCR) investigations to identify root causes and issued Supplier Corrective Action Request (SCAR) to ensure effective resolution of quality issues.

•Responsible for MRB activities for assigned products, timely resolution of nonconformities, issuing and/or monitoring corrective actions associated with nonconformance and deviations.

•Non-conformance product hold for further processing or shipment until non-conformance are resolved.

•Lead and maintained supplier change notifications, deviation, and investigations to meet material requests and process per all applicable procedures and quality requirements. Review Deviations documentation associated with manufacturing operations.

•Resolved supplier quality issues specifically related to production operations disruption.

•Developed an efficient step-by-step PC assembly line, piece them together and wire them correctly.

•Supported manufacturer production line, troubleshoot defects, and resolved related requirements of electronic components such as, hardware, Printed Circuit Boards (PCB), Power Supplies, Cables, etc.

•Worked with buyer/Supply Chain/ and internal receiving and shipping distribution center group on Non-conformance product.

•Review suppliers and customers documentation and purchase orders.

•Used lean, continuous improvement, problem solving, utilize the SCAR/CAPA and other processes to drive quality, delivery, and service improvements.

Process Engineer Feb 2001 - Nov 2002

Micropac Industries Inc. - Dallas, Texas

•Improved quality product and process through area audit, evaluation to company policy and ISO9001 requirements.

Evaluated and modified existing designs, process, and procedure to improve products, including generated (ECNs).

•Coordinated Lean Manufacturing and 5S tools to ensure effective process to increase productivity, cost saving and eliminated Non-Value Added (N.V.A) process.

•Review/write/ & edit, SOP, Procedures, and various Quality related technical documents (specification, work instructions.

•Facilitated the design and development of specialized custom-made tool used to control the location and/or motion of parts or other tools and fixtures for handling devices.

•Certified Internal Auditor appointed by the Internal Quality Department and a member of lean team.

•Participate verification and validation documentation of equipment Insulation Qualification (IQ).

•Performed verification and validation of Operation Qualification (OQ)/Process qualification (PQ).

•Supported and resolved failure component and equipment in manufacturing production line and clean room.

•Leads investigations on identifying root causes of product failures of customer returned, respond to customer with 8D problem solving report for Corrective and Preventive Action (CAPA).

•Supported manufacturing, production line, troubleshoot defects, and Pull Test for wire bonding that used to connect an IC to other electronics or printed circuit board (PCB).

•Worked with manufacturing to resolve defective material issues, using root cause analysis and corrective and preventive actions (CAPA). Support audit, NCR, CAR investigation and report.

Quality Assurance Engineer July 1989 – Sep 2000

Texas Instruments Inc., Military Department. - Dallas, Texas

•Served as a lead to five technicians and two clerks’ day to day assignment work and providing direction, and managed department in absent of department Manager.

•Reviewed and approved New Product Development (NPD) per (QSS), (QSM) and military standard, MIL-STD 883, MIL-PRF-38535 and ISO 9001. Daily quality engineering support of manufacturing operations.

•Lead and responsible engineer for customers return products. Performed Root Cause (RC) and Corrective Action and preventive action (CAPA) by provided technical 8D problem solving report to customer based on F/A and Root cause analysis (RCA) that identifies the cause of a discrepancy. Participates in and supports internal audits and regulatory authority inspections, as required.

•Participate verification and validation documentation of equipment Insulation Qualification (IQ).

•Performed verification and validation of Operation Qualification (OQ)/Process qualification (PQ).

•Participate in developing prototypes, process to support manufacturing.

•Provide inputs to product and design verification and validation plans.

•Review, revised, edit, SOP, Procedures, and various Quality related technical documents (specification, Traveler, work instructions, batch records, etc. Support product change order (PCO) process.

•Reviewed Inspection/Audit results/Failure reports/Customer documentation, and other areas as required.

•Participated in Design Control process (Design Input, Design Output, Reviews, Qualification, and validation.

•Knowledge of quality methods, verification/validation processes, inspection/testing, Quality standards, nonconforming issue, material identification, disposition, and scrap.

•Evaluated and modify existing design, process, and procedure to improve products, including generated Engineering Change Notices (ECNs) and crate and resolved deviations.

•Worked directly with customers to address issues concern product quality and provided solutions.

•Developed and managed qualification plan activity to produce the new product (NPD).

•Developed procedures for incoming, in process, and final inspections for new product development.

•Lead team on Root Cause Analysis (RCA), Corrective and Preventive Actions (CAPA) and continuous improvement.

•Participated in and conducted internal quality audits for company ISO 9001 certification.

•Implemented Lean Manufacturing in production line with focus on quality and customer satisfaction.

END

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