Jeffrey A. Shriner

*** ******* ******

Conshohocken, PA 19428

610-***-****

adt60r@r.postjobfree.com

Overview of Qualifications

** ****'s Quality Engineering Disciplines, Supplier Quality Engineering, Design Quality Engineering, Validation Engineering, New Product Development and QMS (Quality Management Systems) across multiple industries and many manufacturing environments Volume Manufacturing Environments. QMS (Quality Management Systems) Experience includes ISO 13485:2016, 21 CFR Part 820 Quality System Regulation. QMS Gap analysis and procedure upgrades for EUMDR compliance. PLM (Product Life Cycle Management), Supply Chain Management and Supplier Risk Assessment. Failure Investigation, CAPA (Corrective and Preventive Action. PFMEA, Control Plans, MSA (Measurement System Analysis), FDA MDR (Medical Device Reporting). IQ, OQ, PQ completion for Class 2 and Class 3 Medical Devices. TMV (Test Method Validation). Aerospace AS9100D, APQP Development, FOD Controls, Flight Critical Product Source Inspection, Supplier QMS and Process Auditing. Automotive Industry IATF 16949:2016. PPAP development and submission. ISO 9000:2015 Upgrades. Lean Manufacturing. Advanced Statistical Techniques. Product and Process Validation. Certified GD&T Metrology Expert in Mechanical Inspection. CAD Modeling in ProE and Solidworks. Extensive background in Fabricated Metals, Machining, Screw Machining, Castings, Forgings, Anodizing, Plating, Heat Treating and NDT (Non-Destructive Testing). Injection Molding, Insert Molding, Electro-Mechanical Assemblies and Fasteners. Expert-Advanced GD&T, High Precision Inspection, Measuring and Test Equipment. GD&T and interpretation of Geometric Drawings for Complex Fabricated Components, Electro-Mechanical Devices and Assemblies. ASTM and NIST Technical Specifications for Material Physical Properties and Performance Testing.

Contract Organizations 2015 to Present

2022 - Zimmer Biomet - Principle Quality Engineer

2021 - L3Harris Technologies - Senior Quality Engineer/Specialist

2021 - Thermo Fisher Scientific - Metrology/Validation Engineer

2019 - Johnson & Johnson, Quality Engineer lll

2018 - 2020 - W. L. Gore and Associates - FAI Specialist, Senior Quality Engineer

2017 - Johnson & Johnson - Quality Engineer lll

2016 - Johnson & Johnson - Quality Engineer ll

2016 - 2018 - SpaceX, Source Inspector, Auditor

2016 - Harris Electronics - Supplier Quality Engineer

2015 - General Dynamics - Quality Engineer

Contract Job Titles 2015 to Present

Principle Quality Engineer, Senior Quality Engineer, Metrology/Validation Engineer, Quality Engineer, Supplier Quality Engineer, PLM Lead, QMS Compliance Specialist, FAI Specialist AS9102, Senior CAPA Engineer, APQP SME, QMS Lead Auditor, GD&T Metrology Engineer, Source Inspector, CMM Programmer.

Contract Responsibilities 2015 to Present

Telemetry East Division ASD9100D Compliance. Fulfill Government Contract Purchase Order Requirements. Develop and Present AS9102 FAI (First Article Inspection) Records for all DOD and Government Contracts. Create and execute IQ, OQ, PQ Validation Protocols. Direct and conduct MSA activities. Lead Inspection personnel through equipment and product validations. CTF Design Inputs, CMM Calibration, Author and approve Inspection Plans, Gap Analysis, EUMDR QMS Migration, document upgrades and progress reporting. PLM system migration and document upgrades for EUMDR compliance. PLM administration for new and existing products. Responsible for all quality assurance initiatives and product validation activities relating to the manufacture of Class 2, 3 Medical Implants and Surgical Instruments. Supplier Gap Assessments and Pre-Contract Approval qualifications. APQP (Advanced Product Quality Planning). FAI (First Article Inspection). FMEA (Failure Mode Effects Analysis). Control Plans with Process Flow Diagrams. Product Source Inspection and product approvals. Nonconforming product containment and recall. ZDP (Zero Defect Program) implememtation and training. CAPA (Corrective and Preventive Action) 8-D and 5Y root cause investigation and analysis. New product development. Design Quality Engineering. Product Team Leader, Risk Assessments and RPN classifications.

Principle Engineer

Zimmer Biomet, Zimmer Knee Creations

Exton, PA

Jan, 2022 to Sept, 2022

Site remediation oversight. Conducted FDA product transfer supporting consolidation of manufacturing operations and facility closure.

Senior Quality Engineer, FAI Specialist

L3 Harris

Bristol, PA

May, 2021 to Jan, 2022

Support Telemetry East Division compliance to ASD9100D. Fulfill Government Contract Purchase Order Requirements. Generate and pprovide AS9102 FAI (First Article Inspection) records for all DOD customer government contracts.

Metrology/Validation Engineer

Thermo Fisher Scientific

Fairport, NY

Jan, 2021 to May, 2021

IQ, OQ, PQ Validation Protocols supporting new product design/development, validation protocols for new tooling and combination injection molding/blow molding processes, validation protocols supporting new metrology lab at Fairport facility. Measurement System Analysis (MSA) for new product development and new CMM’s. Provided CMM programming support, software training for metrology lab employees and metrology lab equipment validation.

FAI Specialist, Quality Engineer

W. L. Gore and Associates

Newark, DE

Nov, 2018 to May, 2020

Planned and coordinated all activities associated with generating, completing, and submitting First Article Inspection Reports (FAI’s) to AS9102 and as required by W. L Gore and Associates aerospace customers, purchase order requirements and applicable PO quality clauses. Provided technical guidance and direction to corporate leadership, company stakeholders and divisional managers for ongoing compliance to AS9100D. Led efforts to adopt and implement Advanced Product Quality Planning, (APQP) methodologies, coordinated Zero Defect Program (ZDP) rollout and streamlined internal processes to generate, submit and maintain FAI’s as required by aerospace customers and all government contracts.

Johnson & Johnson

Westchester, PA

2016 to 2017

Maintain compliance with FDA 21 CFR Parts 808, 812 and 820 (CGMP) requirements for Current Good Manufacturing Practices in the design and manufacture of medical devices and surgical instruments.

Quality Assurance Engineer III

Kensey Nash Corporation

Exton, PA

2011 to 2014

Maintain compliance with FDA 21 CFR Parts 808, 812 and 820 (CGMP) requirements for Current Good Manufacturing Practices in the design and manufacture of medical devices and surgical implants. CAPA root cause investigation and analysis. CAPA workflow management and controls using PTC Windchill. Annual Internal audits for compliance to ISO 13485 requirements. Confirmation and resolution of customer complaints and supplier issues. Performed First Article Inspections, TMV, IQ’s, OQ’s and PQ’s for all new parts and assemblies. Responsible for the acquisition, installation, qualification and training of advanced inspection equipment which included multi axis CMM’s, Non-contact inspection equipment consisting of multiple Keyence IM 6120 machines, Micro-Vu Vertex machines, Nikon Metrology LC15DX Laser Scanning probe system with Focus and PolyWorks 3D Scanning software.

Quality Assurance Engineer

Crescent Industries

New Freedom, PA

2009 to 2010

Quality engineering support to maintain compliance with ISO 13485 and FDA 21 CFR requirements. Responsible for CAPA system maintenance including NCMR’s, SCARS, and immediate resolution of all customer and supplier issues. Purchased an Optek multi axis CMM and trained Inspectors on the use of both the equipment and the software functions. Performed and approved First Article Inspections as needed. Trained Inspectors in proper use of inspection and test equipment and associated documentation required by customers. Reduced time required to provided customers with product and process validations. Trained Machine Operators to perform in process inspections at the workstations. Coordinated inspection and test methods with customers to assure processes were being performed under the same conditions. Constant communication with customers to resolve design issues as part of meeting the requirements for Contract Review. Worked closely with customers to provide product improvement recommendations to enhance manufacturing repeatability and reliability.

Manager Quality Assurance

FPI Topcraft

Warminster, PA

2006 to 2009

Attained ISO 9001:2000 and ISO/TS 16949:2002 Certifications. Assured ongoing compliance to ISO 13485 FDA standards and regulations for all Medical Device Products. Maintained compliance to all Quality System requirements for all customers. Prepared PPAP documentation for Automotive Customers including APQP’s, Control Plans, PFMEA’s and Process Capability Analysis. Problem Root Cause investigation and analysis. 5 Why and 8-D problem solving techniques. UL plant requirements and compliance. Coordinated daily MRB activities. Supervised Quality Assurance Staff for all shifts. Resolved all customer problems in a timely manner and maintained all Inspection and Test Equipment.

Contract Quality Engineering

Metrology, QMS, PLM & ERP Automation

Bryn Mawr, PA

1997 to 2005

Provided contract engineering, quality assurance and computer network administration services to a diversified client base throughout the greater Philadelphia region. Contract assignments included quality system development to ISO 9000, AS 9100 and QS 9000 compliance. Conducted gap analysis and quality system assessments. Performed 3rd party supplier assessments on a contract basis. Evaluated measurement system capabilities. Developed, marketed, and provided custom quality assurance software solutions to comply with international standards and specifications. Conducted source inspections and FAI approvals as needed. Provided a full range of computer network administration and support services to area clients.

Quality Assurance Manager

Randolph Mfg.

Easton, PA

1994 to 1997

QS 9000 and ISO 9000 quality system compliance for direct supply to the automotive and electronic industries. PPAP Submissions, PFMEA, FMEA, SPC, JIT, ZERO Defects. Quality System implementation and administration. Quality engineering in machine shop and metals fabrication environments working with steel, aluminum, brass, copper, and specialty alloys. Blueprint reading and geometric dimensioning and tolerancing. SPC controls for high volume CNC automatic screw machining operations. Product manufacturing to procedures in accordance with ISO, automotive, aerospace, nuclear and military standards. In depth process knowledge for CNC machining, screw machining, multi-axis milling, center less and concentric grinding, progressive die stamping, plating, and heat-treating.

Quality Assurance Director

Scientific Group, SP Industries Limited Partnership

Buena, NJ

1991 to 1994

ISO 9000 quality system development planning and implementation. Organized and directed all quality system development activities in accordance with corporate directives to achieve ISO 9001 certification. Performed product inspections and prepared PPAP documentation and product qualification submissions to the automotive industry. Performed source inspections for incoming products and raw materials. Problem root cause analysis and defect prevention. Continuous improvement. Process mapping and advanced problem solving. Customer complaints and problem resolution. Customer quality audits and quality surveys.

Quality Assurance Supervisor

Lockheed Electronics Company Inc. Denville, NJ

1984 to 1989

Managed quality assurance operations in power supply and housing assembly departments. Supervised final product testing operations. Developed and implemented equipment calibration program. Supervised government source inspection operations

Certifications

GD&T, 2010, 2014, 2017

Mechanical Inspector, 2017

Six Sigma Green Belt, 2006

Certified Internal Auditor, 2001

Certified Lead Auditor, 1993

Certified Quality Engineer, 1986

Mechanical Engineer, 1986

Inspection and Test Equipment

CMM’s, Brown & Sharpe, Leitz, Wenzel, Zeiss, Nikon, Mitutoyo, Helmel, Faro

Vision CMM’s, Ram Optical / OGP, Micro-Vu Vertex, Keyence, Optek

3D Laser and White Light Scanners

Optical Comparators, Measuring

Microscopes, SEM

Surface Roughness Testers

Hardness Testers

Force and Tensile Testers

UT (Ultrasonic Test Equipment)

Micrometers, Calipers, Height Gages

Pin Gages, Thread Gages, Dial Bore

Gages, Air Gages

Software

Green Light Guru

PTC Windchill

ProE

Solid Works

Poly Works

Focus Software

AutoCAD

PC-DMIS

Calypso

CMM Manager

Prolink QC-Calc

Measure Magic

SAP

Agile

Baan

Infinity QS

Minitab

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