Quality Engineer Production Operator

Jerry C. Mahan, Jr.

561-***-****/*********@***.***

CORE COMPETENCIES/SUMMARY:

Program and Project Management

Supervision of direct reports

Aerospace, Environmental and Medical

FAA, CFR, ISO, IEC, EU MDR regulations

Airframe and Powerplant

Electrical and electro-mechanical

Quality Assurance and Control

Manufacturing

Product Development

Post Market Surveillance

Regulatory Reporting

Auditing

Clean Room environments

Design for Manufacturing

Design for Assembly

Contract documentation

Supplier Corrective Action

CAPA and Complaints

Supplier Selection and Development

Qualification testing

IQ, OQ, PQ

Class I, II, III devices

Capital Equipment

Document Control

Engineering Release

Non-Destructive Testing

EDUCATION/TRAINING:

BSME Bachelor of Science in Aeronautics – Aircraft Maintenance and Management, Saint Louis University, 1984; FAA Airframe & Powerplant License, 1984; (DAS) Designated Alteration Station Quality Representative, 1990; FAA-DAS Standardization Program, 1987, 1989, 1991, 1994; Quality Alert Institute, Vendor Certification Program, 1991; Boeing Liaison Engineering Structural Repair Program, 1992; Aerospace Industry Association (AIA) Representative, 1991-1995; E-Systems Program Management Training Program 1992-1994; JIT, SPC, TQM, IQUE and ISO 9000. Knowledgeable in military and commercial FAA standards and specifications, contracts, negotiations, proposals, and engineering management.

WORK EXPERIENCE:

Aug. 2021 – Aug. 2022 - Quality Engineering Risk Management, J&J Mentor, Irving, TX. Update and release Risk Management documents to include Post Market data collection and Immunotoxicity Study for implantable medical devices. Perform GAP analysis and Audit Validation Assessments for correct and complete Validation and Verification activities involving IQ, OQ, PQ, Performance Verification and Operational Challenges.

Feb 2021 – May 2021 – Compliance Specialist, ThermoFisher FSI, BMH and Erlangen Divisions. RoHS 2015/863/EU Implementation. Compliance with EU Standards and Directives. Coordinate, collect & process information for global medical device manufacturing suppliers to demonstrate and document compliance to EU MDR requirements. Safety compliance files for products supported by the COE. Communicate with design teams and other internal personnel. Audit internal files and bill of materials to ensure compliance with agency listings regarding the use of appropriate critical components and process corrective actions to resolve adverse internal audit findings with minimal impact and delay to production of laboratory equipment and medical devices.

March 2020 - Nov. 2020 – Supplier Quality Engineer, Depuy Synthes MiTek, Raynham, MA. Conduct and document manufacturing process validations for EU MDR compliance for global supply chain suppliers. Products included Soft Tissue, Orthopedic, Spine and Capital Equipment articles. Review and approval of supplier documentation to support Technical Files and submissions. Participate in cross functional teams.

Jan 2019 – March 2019 – Quality Engineer Consultant at Megadyne, Inc. Salt Lake City, UT, Johnson & Johnson. Technical leadership and lead investigations of causes of non-conformances and process failures. Focus on reliability, risk management, analytics/statistical techniques, requirements management, verification, validation, and design control across the lifecycle of the product.

June 2018 – Nov. 2018- Senior Quality Engineer, Nordson Medical, Minneapolis, MN. Complaint handling, investigations and customer reporting of medical device bio-delivery systems, plastic injection molded components. Perform returned product investigations to review Process, Design and User FMEA Risk analysis. Identify root and contributing causes for device failures and complaints. increase manufacturability and reliability. Coordinate nonconforming material and complaint investigations with contract medical device manufacturer in Mexico. Revise (MWIs) Manufacturing Work Instructions for accuracy, consistency and opportunities for improvement. Work in a team environment to evaluate Design Change impact and implementation of customer, manufacturing, and supplier change requests.

Sept. 2016 – Jan. 2018– New Product Development (NPD) Engineer, Ethicon (J&J) for Endo surgical energy devices supporting multiple development and Prototype projects including combination products. Implementing Design for Manufacturing (DFM) and Design for Assembly (DFA) initiatives. Supplier prototype and production Request for quote (RFQ) including first article inspections, capability, document delivery, Special Process mapping and flow, bio-compatibility testing, performance and functional life cycle testing. Development of extrusion equipment, metal injection molding, coining, stamping and machining operations.

July 2016 – Sept. 2016- Medical Device Compliance and Regulatory Engineer, Vention Medical, Grand Rapids, MI. Evaluation and revision of Production Process documents and procedures geared toward audit reediness and gap analysis in the areas of Process Controls, Test Methods, CAPA and Production Operator Training.

July 2015 – April 2016- Medical Device Compliance and Regulatory Engineer, Terumo CVS, Ann Arbor, MI. PQA support for CAPAs involving design changes to Heart Lung Machine and Blood Parameter/Chemistry Monitoring/Conditioning; Class 1, 2, and 3 Medical devices and combination products. Project support, Feasibility testing, Design Assessment, Design Change Planning, product and procedural changes and compliance auditing/monitoring, RoHS and 60601 Design verification testing. TMV (Test Method Validation), IQ/OQ/PQ, Equipment management and general design evolutions. Process Validation for aluminum and plastics, extrusions and injection molding, tooling and process validation. Technical/design reviews culminating in design transfer activities. Support of multiple project teams on CAPA projects from feasibility to closure including VOE (Verification of Effectiveness).

Oct. 2013 – Dec. 2014- Medical Device Compliance and Regulatory Engineer, Depuy-Synthes a division of Johnson & Johnson, Monument, CO. Manufacturing Quality Engineer supporting production and inspection activities. Responsibilities included Material Review Board, Inspection Methods, investigation and disposition of manufactured and supplier nonconforming material. Manufacturing Engineering activities in high volume skeletal fixation; Class 3; Implantable Medical Devices. Coordination of supplier furnished material acceptance, documentation and returns. New product and design transfer, coordination, and resolution of discrepancies to purchasing and supply chain leads. DHR review and documentation of Design History Files. Manufacturing and Supplier CAPA investigations and closures.

June-2008 – Nov. 2012- MAKO Surgical Corp., Davie Florida. Quality Engineer/Supervisor/Team Leader for multi shift medical device inspection team including CMM and vision system inspection equipment managing activities for 5 direct reports. Reduction of inspection stage and cycle time. Major medical device robotics prototype, development and production article inspection of machined, sheet metal and OTS components. Coordination of supplier and customer inspection and test requirements supporting internal and external robotic installations. ISO 13485 and CFR 820 compliance audits and continuous improvement initiatives. Leadership of the inspection team to satisfy all quality verification requirements from suppliers, supply chain and design validation teams and design transfer qualifications. Develop and improve inspection methods, coordinate production inspection priorities, quarantine, document and disposition of nonconforming material and support of customer service and field installation activities. Design Reviews, FMEA, PFMEA, IQ/OQ/PQ, Product Validation, Supplier Evaluations, Quality Metrics, Audits, CAPA, DHR, failure mode investigations and root cause analysis.

Jan. 1997 – June 2008- CEO of startup business Biozyme Intl, Inc. Independent environmental contractor specializing in bioremediation technologies, applications, state approvals for innovative bioactive products for soil and groundwater remediation across the US. Complete reduction of soil and groundwater contaminates such as petroleum derivatives and complex chlorinated compounds under coast-to-coast state and municipal approval programs within the US.

Jan. 1995 – Dec. 1996- Dexter Tool; West Palm Beach, Florida. Project Engineer/Manager for gas turbine engine component manufacturer & FAA Repair Station. Responsibilities included contract negotiations, customer service, quote preparation, purchasing, production planning and estimating, subcontract administration, creation, and maintenance of manufacturing multi-level bill of material structures and Inspection documentation. Customer base included Pratt & Whitney, Rockwell International, Lockheed Space Operations, NASA as well as multiple foreign governments and international aerospace and industrial prime contractors.

July 1987 – Dec. 1994- E-Systems Inc.; Greenville Texas Division. Senior FAA Procurement Quality Engineer in charge of Repair Station administration activities. Senior Quality Assurance Engineer for the Procurement Quality Assurance Department. Program Quality Representative for FAA Experimental Aircraft Certification and Supplemental Type Certification Programs. Responsibilities included supplier audit and selection, source inspections, equipment certification issues including development and testing of airframe structural components and assemblies, travel throughout the US in support of supplier development and testing. Conduct conformity inspections and qualification testing, supplier program quality budgets, contract scheduling and status reporting, supplier surveillance and certification, liaison activities between customers, departments, and suppliers. Testing and safety activities involving Electrical and electromechanical assemblies including EMI, EMC, shielding, circuit testing, lightning strikes, conformity and compliance test protocols.

Quality Control Supervisor on Special Air Mission (SAM) Boeing 747 Progressive Depot Inspection/ Maintenance operations including presidential Air Force One. Supervisor of up to 25 Quality Control Inspectors for Progressive Depot Inspections and aircraft modifications and repair, coordination/liaison between Engineering, Production, Planning, Parts Control and Program Management.

Fabrication Shop Quality Assurance Engineer developing and implementing First Article Inspection Procedures. Conformity inspections of prototype castings and machine parts for new/improved engineering designs, initiate resolutions to design and fabrication difficulties, develop and maintain specific work instructions.

Quality Control Inspection of Electrical Black Box Assembly Department. In-process and final assembly inspections, functional test and verification of all types of electronics and printed circuit board articles, maintain component item configuration control of production assembly and developmental pilot assembly components.

Aug. 1985 –June 1987- United Engineering Co; Saint Louis, MO. Lead Quality Inspector for machined part component manufacturer. Inspection of CNC machined aircraft structural components and tooling. Liaison Engineering, nonconforming material drafting, technical writing and customer submittals.

Contact this candidate