Risk Management Quality Systems

Shahan Stephanian

Cell: 626-***-****

ad5rt0@r.postjobfree.com

**** ******** ***., ********, ** 91107

Summary:

A Project Leader Quality/Regulatory Affairs professional with over 9+ years of GMP experience working for Medical Devices companies; managing in FDA 21CFR Parts 820, 210 and 211 Quality System Regulation, ISO 9001, ISO 14971, ISO13485, and ISO 11979 Standards, as well AS 9100 quality systems.

Execute several internal and external audit functions; providing oversight role to lead the Quality Systems and Supplier Management of the Ophthalmic, Surgical & Vision Business Instruments and IOL products, Home Care Oxygen Therapeutics, IVDR Immunoassay and Diagnostic Urine Analysis products, Hard Valve Medical Device products and Infusion Pump Implantable Drug Delivery products. The role includes three key functional leadership aspects:

As effective and analytical result-oriented leader in decision making, problem solving, and team building skills with strong knowledge of domestic and international regulations including CMDR, MDD, ANVISA, KFDA, JPAL, Clinical Laboratory Standards Institute (CLIA), MDR and IVDR standards.

Apply GAMP-5 application software system requirements for the non-product software includes custom applications, spreadsheets, vendor configured systems and off–the-shelf software.

Extensive experience releasing complex products, post-market surveillance and FDA remediation projects requires the ability to make sound decisions based on scientific and regulatory knowledge.

Highly efficient quality project-management such as scheduling project plan and risk matrix skills; manages multiple priorities within demanding environment. Hosted and managed several FDA and State Board inspections and Notify Body audits (front and background rooms).

Qualifications:

Subject Matter Expert in the following Quality core competencies:

Design Control

Risk Management

Post-Market Surveillances

Test Method Validation

Design Verification & Validation

Process Validation

Supplier Management

Software Verification & Validation

Reliability Engineering

Statistical Methodology

DMAIC Methodology

CAPA/NCR

First Article Inspection

Geometric Dimensioning and Tolerancing (GD&T)

Skills:

Computer Software skills and languages: MS Word, Assembly language, Reliability RELEX (reliability analysis-software prediction program), EDMS, Salesforce, Agile, Minitab Statistical Software, CMM, and Smart Scope programs.

Education:

Electrical Engineering Continuing Education (Master Program) - California State University

Bachelor’s degree in science – Applied Physics

STAT-A-MATRIX Institute - Huntington Beach, CA

VLSI/LSI Semiconductors Technology at UCLA

Bioengineering Extension Courses at Cal State Northridge University

Certifications:

Certified GMP/ISO 9001/13485:2003 Internal Auditor, sponsored by STAT-A-MATRIX Institute.

Certified ISO 9001 Auditor/Lead Auditor, sponsored by (QASNA) Huntington Beach – California

Certified “VLSI/LSI Semiconductors Electronic Technology” UCLA short courses program – California

Certified “Six-Sigma - Green Belt” by Bausch & Lomb program.

Certified Supplier Quality Auditor by Bausch & Lomb program.

Certified Problem-Solving Process (PSP) by Danaher Corporation.

Certified Kaizen training program by Danaher Corporation.

Certified Product and Non-Product Software & Risk Management provided by Danaher Corporation.

Professional Experience:

Philips Respironics, Inc. March 2023 – Present

Senior Design Quality Engineer/Lead Risk Management Specialist (Remote)

Product Line: Ventilator, Sleep Apnea, Oxygen Concentrator and Use Interface accessories.

Collaborate at system level with R&D, Clinical, Medical Affairs, and Software team and others to develop a quantitative approach to the Risk Management process for Remediation project.

Lead cross-functional team to identify risks, implement risk control measures, and document a robust and living Risk Management File.

Handled major post-market projects where CAPA and investigation were crucial. Involved impact assessments elevated to hazard analysis.

Worked as an in charge of the CAPA department and handled preventive actions by following pathways of root cause analysis, investigation, and then verification implementation processes. This included risk assessments based on design control.

Facilitate the creation/update of mapping of Risk Management documents – hazards identifications,

hazardous situation analysis, sequence of events, harms, P1, P2 and POH calculations and principles, and risk control measures, including design control design for reliability and failure rate calculation, process and use FMEAs throughout product lifecycle, benefit-risk assessment, and risk review reports.

Conduct analysis of existing similar products to provide documented compliance and evidence of State of the Art, as part of periodic Risk Management File updates.

Assures products meet regulatory requirements for Risk Management, including FDA, QSR, MDD,

EU MDR, CMDR, ISO 13485, ISO 14971, IEC 60601, EN 62366, EN 62304, and client internal Philips policy and procedures.

Conduct post market Issue Impact Assessment, Health Hazard Evaluation tasks to ensure the risk management process supports the Complaint Handling and CAPA activities.

Review and assess the quality systems, CAPA, DHF, DHR records related supporting to the design control, risk management file and quality systems.

Ensures the systematic and logical conversation of customer requirements to design product specifications and post-market surveillance codes.

Create and continually improve procedures and work instructions to endure reliable, and repeatable results.

Cognos Therapeutics Inglewood, CA Jan 2020 – Feb 2023

Principal Design Quality Engineer & Regulatory Compliance

Product Line: Implantable Infusion Pump System and Accessories

Plans, directs, and implements all quality aspects of the company's design and development of new implantable medical device products or software systems, with detailed focus on software hazard analysis, risk management, cybersecurity, and patient safety.

Handled day-to-day activities such as incoming inspection of received materials, release, and assembly. Captured all processes and anomalies and followed inspection protocols. Good documentation practices were crucial, ensuring dates and signatures for GMP compliance.

Support third party QMS and product safety compliance audit, ensuring all elements of quality systems are being managed and implemented effectively in timely manner.

Collaborate with cross functional team by applying the knowledge of Design Control, Regulatory and Quality Engineering principles and techniques to positively influence product development efforts, including in systems, hardware and software development areas, Software Configuration Management, Risk Analysis, Human Factors, Specification Development, Design Verification, and Design Validation.

Oversight for the supplier contracts and their manufacturer quality programs, process and procedures.

to ensure in compliance with Cognos policy and quality standards and requirements.

Schedule and execute internal and external quality audits to ensure QMS, RoHS, and FDA QSR compliance for devices requirements, including combinations products, as applicable.

Leads risk management activities throughout the product life cycle, including Preliminary Hazard Analyses, Design and Use Failure Mode & Effects Analysis. Ensures appropriate statistical methodology is employed during development efforts.

Work with product development engineering and manufacturing engineering to translate design requirements into manufacturing requirements to achieve design for manufacturability.

Provide support to the manufacturing assembly and fabrication processes by developing production flow-charts, work instructions, and preparing critical to quality (CTQ) inspection points in compliance with GLP/GMP/GDP regulations.

Responsible for reviewing and approving the drug-device products distribution systems and ensuring in compliance with local and federal agencies regulations.

Provide guidance for the combination products in development and manufacturability and assure the regulatory and quality requirements are attained.

Drive predictive engineering methodology incorporating reliability (MTBF/MTTR) studies and capability analysis assessments in device design control and manufacturing processes.

Ensures test methods validation and drug-device stability studies are appropriate and validated for use.

Participate actively as contributor for the FDA pre submission projects.

Work with product safety and biocompatibility outsourcing test laboratories to ensure the qualification and testing specifications with applicable regulatory requirements.

Conducted internal audits for medical devices, covering all elements of the Quality System Regulation (QSR). Exposure to pharmaceutical audits using CFR regulations for drug and device solutions and worked in ISO 5, 7 and 8 environmental control standards.

Hybrid Systems Corp - Glendale, CA Dec 2018 – Jan 2020

Quality Assurance Manager

Product Line: Medical Devices, Aerospace and Commercial Products

Oversaw the daily quality systems task assignments of direct reports as well as supervise and prioritizes tasks as necessary to assure schedule compliance.

Performed the supplier selection and qualification activities using various incoming and in process inspection (e.g., Keyence inspection tool) for received laser welded subassemblies and parts.

Implemented 21 CFR 820, ISO 13485:2016, AS 9100, ISO 9001, IPC J-STD-00, IPC-610, IEEE standards and RoHS requirements.

Followed supplier and vendor interactions and compiled documentation as per GMP regulations. For sterilization, items were sent outside the facility as per workflow. Also managed packaging, labelling, and addressing damaged labels before shipping finished goods. Additionally, handled backfill quality department tasks.

Prepared and execute product and non-product software validation protocols and reports to comply with customer's policy and procedures.

Prepared Software Requirement Specification (SRS), and Software Hazard Analysis per applicable standards and procedures.

Collaborated with software engineering to provide guidance for non-product software validation as part of the technical support to the client quality system and compliance activities.

Managed post-market surveillance to oversee all complaint handling, risk assessment and investigation processes and initiates, implements, and coordinates corrective and preventative actions as appropriate.

Performed Interface with design, inspection and manufacturing personnel on technical issues, specification requirements, inspection methods and scheduling.

Reviewed and approved all revisions to the internal process procedures and Quality system procedures to assure that documentation meets current regulatory and customer requirements.

Scheduled and reviewed internal and client external audits to assure that any out of compliance with product, processes, or procedures are identified, documented, recorded, and corrected.

Represented Company during all customer and regulatory audits.

Reviews all data obtained during all quality control and assurance activities to ensure consistency with company goals, policies, and procedures.

Kept management team abreast of significant issues or developments identified during quality activities and CAPA actions being taken to assure continuous process improvement.

Designed and implemented training programs to all quality and production personnel in compliance with good documentation practices (GDP) and good manufacturing practices (GMP).

Johnson & Johnson Surgical Vision - Santa Ana, CA Mar 2018 - Nov 2018

Lead Design Quality Engineer (contract)

Product Line: Cataract Surgery, Laser Surgery, and Consumer Eye Health products

Full Remediation of DHF, RMF and HFEs for CEH, Capital Equipment, IOLs and Third-Party Manufacturers (TPM).

Supported the development for Design Trace Matrices for between customer requirements, design input, design output, design verification, design validation and design transfer.

Developed/Updated Risk Management templates and processes, which includes the Risk Management File, gap assessment and remediation activities.

Performed Design History File Gap Assessment and Remediation, Post-Market Surveillance and Human Factor Engineering Gap Assessments for FDA Remediation projects.

Communicated and coordinated with the suppliers and contract manufacturers to ensure design assurance-driven initiatives meet the company’s conformity requirements.

Beckman Coulter Inc - Chatsworth, CA Nov 2014 - Jan 2018

Staff Design Quality Engineer & Regulatory Affairs

Product Line: In Vitro Diagnostic (IVDR) Urinalysis Systems, Reagents and Consumable

Directed, developed, and executed strategic planning that directs Design Quality activities and aligns with the Quality Systems, New Product Development, New Supplier Selection and Monitoring, Internal External Audits, and Regulatory Affairs Submission projects.

Prepared and maintained Design History File (DHF) for Remediation projects according to the Company strategies that include the extended projects for FDA 510K submissions and updating the Technical Files per applicable EU standards.

All Remediation verifications, clinical performance evaluation and product validations protocols are being executed at module, instrument, and system levels.

Provided leadership and compliance within Design Quality organization of delivering on time per the objectives for new product introduction (NPI) and design for manufacturability requirements.

Collaborated with the sustaining quality and manufacturing engineering in developing production flow charts, assembly and inspection instructions, as well operators training programs.

Partnered with all functions including R&D, Clinical & Regulatory Affairs, Product Development, QA Ops and Program Management to translate software life cycle development (SLCD) and electromechanical system requirements into robust & consistent implementation practices.

Developed and maintained Design Quality, Risk Management, Software and Hardware Configuration Management, Post-Market Surveillance and Reliability projects that consistently assure product performance and satisfies the intended use of previously determined customer expectations.

Lead the on-going audit readiness of design related and quality systems, CAPAs, complaint handling and risk management support. Interfaces with external Regulatory & Audit Agencies in matters related to design controls and quality systems.

Medtronic Inc - Northridge, CA Jun 2014 - Oct 2014

Quality System Engineer/Risk Management Specialist (contract)

Product Line: Insulin Infusion Pump and Accessories

Reviewed and assessed risk management document, including FMEA and FTA, risk management plan and report and risk analysis documents, risk-benefit, and assurance case reports.

Developed and implemented risk assessment techniques in compliance with IEC 60601-1 EN 62304, EN 62366 and ISO 14971 standards in supporting the Remediation of the risk management process.

Worked closely with cross-functional team in development of thorough, accurate and practical risk estimations, risk control measures and risk/benefit analysis.

Analysed production and field data for field returns and determine if the changes to product risk profile have occurred; initiate and coordinate risk control activities as required.

Updated legacy product risk management documentation to comply with current risk management process and meet the remediation plans and regulatory requirements.

Dexterity Diagnostic, Inc - Rancho Dominguez, CA Dec 2013 - May 2014

Quality Assurance Specialist (contract)

Product Line: In Vitro Diagnostics (IVDR) and Medical Device products

Developed written policies, procedures and work instructions required for building the quality system under IVD medical devices regulations.

Performed tasks required to support design control process, such as risk analysis, design verification, engineering change order and new supplier qualification and monitoring system.

Provided the software quality support to the LIMS software system (non-product software tools) for qualifying new software contractors.

Executed several software and hardware validation protocols for the installation of new temperature and humidity monitoring and wireless control systems.

ResMed Motor Technologies - Chatsworth, CA Apr 2013 - Nov 2013

Global Quality Assurance & Regulatory Affairs Director (contract)

Product Line: Sleep Apnea, and Sleep Dental Implants

Established clear processes and metrics in line with business strategy and regulatory requirements.

Maintained External References and implement, per applicable national and international regulations, standards and FDA guidance documents that affect the products and operations.

Performed the role of management representatives and interface with FDA and Notify Body auditors.

Worked with R&D and Manufacturing to establish quality plans and ensure quality objectives are met.

Collaborated with CAPA Owners to manage CAPAs in the system to ensure they are well planned, effective, and completed in a timely manner.

Directed and managed strategic and tactical quality operations and supplier management for company.

Communicated group performance against established metrics to senior management.

Monitored proposed regulatory changes from the FDA and other agencies including worldwide regulatory authorities and provide management with impact of changes in the Regulatory environment.

Bausch & Lomb Corporation Rancho Cucamonga Site, CA Mar 2006 Mar 2013

Global Principal Quality Engineer & Regulatory Compliance

Product: Implant Intraocular lens product (IOL) /Injector devices/and Eye Drops

Ensured the R&D new and existing products development portfolio and sustaining of the current medical devices. Assures adequate resources are present to represent design QA function and to support the company growth. Provides leadership on product project management boards and works closely in conjunction with R&D, Regulatory Affairs, Clinical, Process, and Manufacturing.

Submitted to the FDA several 30-Days Notices,135-Days Premarket Approval (PMA) Supplements for manufacturing method and process changes.

Ensured that all site quality performance indicators (KPI) metrics presented to the management.

Worked directly with operating entities to ensure that supplier management controls, product life cycle requirements including risk management, inspections, lean manufacturing, six-sigma, root cause analysis tools, statistical process control analyses and internal & external audits are conducted on a continuing basis as specified to enforce requirements and meet specifications.

Established the development and maintenance of the quality assurance programs; policies, processes, procedures, and controls ensuring that performance and quality of products conform with establish standards and agency guidelines.

Responsible for releasing and distributing medical and pharmaceutical solutions to the designated domestic and international company’s distribution centres, as well as involve and interface with third party and FDA audits and inspection.

Reviews, analyses, and reports on quality discrepancies related to products manufactured and works closely with manufacturing to develop disposition and corrective actions for recurring discrepancies.

Directed and coordinated all aspects of site strategic planning and quality assurance programs, such as development and administration, training, coaching employees, and facilitating through organization.

Responsible for the organizational structure changes/alignment with B+L corporate quality system.

Responsible for managing the quality integration plan into the transformation Plan: NC/CAPA CAMS 2.0, Change Management, Documentum 6.5 and Compliance Wire.

Performed Quality Planning Tool to assess site quality systems versus global supplier quality system and where needed make appropriate changes to the local quality systems.

Represented the site externally with domestic and international regulatory agencies to provide information and solve problems.

Developed and implemented procedures for inspecting, testing, and evaluating the precision, accuracy, 1st Article Inspection, and reliability of new and current suppliers' products.

Monthly reporting to the senior functional management on the CAPA/NC and Complaint handling performance activities using Salesforce system.

Managed site internal and external audit preparation ensuring all elements of quality systems are being managed effectively and in timely manner.

Participated in industry and regulatory surveillance to ensure that the highest standards are maintained through on-going communication and training.

Responsible for leading development and management of effective compliant quality systems, working closely with various cross functional members of site to ensure all requirements described meet the needs of regulations and functional excellence.

Assisted in the development and monitoring of department budget.

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