Jeffrey — Quality Assurance Engineer III

2014 to present Responsible for all quality assurance and validation activities relating to the manufacture of Class 3 Medical Implants and Surgical Instruments by external suppliers. Planed and conducted 3 rd party QMS (Quality Management Systems) assessments at medical device and aerospace supplier facilities. Managed sub-tier supplier validation and APQP (Advanced Product Quality Planning activities for FAI (First Article Inspection) submissions, FMEA (Failure Mode Effects Analysis), Control Plans for risk management assessment and mitigation. Conducted product source inspections at supplier facilities. Containment and disposition of nonconforming product. Supported ZDP (Zero Defect Program) quality initiatives and provided training at supplier facilities. Facilitated CAPA (Corrective and Preventive Action) and perform root cause investigation and analysis. Implemented and executed validation protocols for all new products from design to product realization. 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 Engineer Engineering and ERP Business Systems Services, 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 3 rd 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 Manufacturing, 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. Blue print 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 Engineer Lockheed Electronics Company Inc., Denville, NJ Denville Division

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