Senior Quality Engineer
Senior Quality Engineer - Medical Device
Company is a globally-recognized contract manufacturer of injection-molded components and assemblies. The company is a privately-held, financially strong organization with more than 87 years of success, currently serving the medical device, automotive and commercial electronics markets. The company offers its customers services from design for manufacturability and project management through injection molding, assembly, packaging and sterilization management. For its medical device customers, the company functions under ISO 13485 certification and FDA and GMP compliance and operates a state-of-the-art, FDA compliant Class 8 (100, 000) clean room. The company currently serves a diverse group of international medical device OEMs.
Position Summary: • Establish best-in-class processes for all IQ, OQ, and PQ protocols and validations in support of the program launch activities andThe company SMART Launch Process. • Be responsible for quality assurance and regulatory compliance activities in support of new product introductions and engineering changes. • Assure compliance with The company quality systems and standards (ISO 13485, and related quality regulations and requirements, including FDA, cGMP) per PMC’ s quality strategies and directives. Key Performance Indicators include: • Being part of a team-oriented focus on delivering programs on time, at quality, and at quoted cost to customers. • New tool launches that meet First Time Quality (FTQ) standards. • Timely IQ/OQ/PQ protocols/validations that meet or exceed customers’ requirements.
Main Responsibilities: • Represent the Quality function during new Product Development Process and Design Reviews. o Define deliverable QA requirements as inputs to project plans. o Actively participate in product specifications and design control, including: quality planning, PFMEA, risk analysis, biocompatibility, sterilization (cleanliness specs), design review, and packaging/shelf-life study activities, etc. o Develop, validate, document and refine QA Test and Inspection procedures. Select and acquire equipment/tooling as required to meet product requirements and specifications. o Develop Process Validation Master Plans and IQ/OQ/PQ Protocols. Define sampling plans with statistical rationales, process control plans, and supply SPC to manufacturing applications. Set-up SPC programs and drive improvement based on the evaluation of results attained. o Evaluate/recommend QA sampling plans based on desired confidence limits, process capabilities and manufacturing/inspection methods and equipment. • Personally participate in customer meetings to understand and negotiate validation requirements for customers’ new product launch activities and translate into protocols. • Participate in quotation activities to compile validation protocols and costs within customer quality requirement documentation. • Actively participate in the development, on-going maintenance and improvement of PMC’ s quality systems, to include: quality planning (short and long term); supporting diagnosis and resolution of quality problems (internal and external); corrective and preventative action programs; quality system audits; and, continuous improvement programs. • Continue to develop personal knowledge and skills in quality systems/standards by networking and pursuing continuing education.
Senior Quality Engineer – Medical, Nov 2016
• Follow and support the Company’ s confidentiality obligations and maintain protection of the Company’ s and customers’ proprietary information.
Reporting Structure: • Position reports to the VP of Operations and Engineering.
Compensation Program: • Competitive base salary, commensurate with experience, skills and accomplishments. • Additional incentive bonus opportunity. • Full benefits program. • Relocation assistance available.
Candidate Requirements: This position is an action-oriented, “ hands-on” job. Successful candidate’ s experience will demonstrate this job behavior, along with a track record of proactive problem-solving. • Bachelor’ s degree in quality engineering or related field is strongly preferred; or, an equivalent level of technical education and related quality engineering experience is required. • Minimum five (5) years of manufacturing experience is required, with at least three (3) years of recent experience as a Quality Engineer in a medical manufacturing operation. Medical device plastic injection molding experience is a strong plus. • ASQ certification in one or more areas (CQE, CQA, CQM, etc.) is required. • Extensive working experience with ISO 13485/FDA/cGMP quality standards is required. • Demonstrated experience in developing and writing medical IQ/OQ/PQ protocol/process validations is required. • Demonstrated strong written communications skills, with a high level of computer literacy in MS Word and Excel are required. • Experience with successfully leading quality problem-solving teams, in a “ hands-on” role, is required. • Demonstrated experience with direct customer communications and negotiations is required. • Experience working in a cleanroom environment is a strong plus. • Some overnight travel, about 5% - 10% of work