Quality Engineer

PMC Smart Solutions LLC•Shelbyville, IN

About The Position

PMC, as a globally-recognized, award–winning contract manufacturer, provides life-saving medical devices and safety-enhancing automotive components to a broad base of international, market-leading OEMs and Tier One customers, including Medtronic, Stryker, Bausch & Lomb, Baxter, ZimmerBiomet, Olympus, Bosch, Continental and others. PMC offers services from design for manufacturability and program management through injection molding, full assembly, packaging and sterilization management, focusing on precise-tolerance, intricate devices and components. For its medical customers, PMC functions under ISO 13485 certification, FDA registration and operates state-of-the-art, certified Class 8 (100,000) clean rooms. PMC is a certified Women-Owned Business Enterprise, offering a comprehensive range of services while supporting global OEMs’ supplier diversity goals. POSITION SUMMARY Establish best-in-class processes for all IQ, OQ, and PQ protocols and validations in support of the program launch activities and PMC’s SMART Launch Process. Be responsible for quality assurance and regulatory compliance activities in support of new product introductions and engineering changes. Assure compliance with PMC’s 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: 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.

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.
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.
Some overnight travel, about 5% - 10% of work time including some limited international travel, is required.

Nice To Haves

Medical device plastic injection molding experience is a strong plus.
Experience working in a cleanroom environment is a strong plus.

Responsibilities

Represent the Quality function during new Product Development Process and Design Reviews.
Define deliverable QA requirements as inputs to project plans.
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.
Develop, validate, document and refine QA Test and Inspection procedures. Select and acquire equipment/tooling as required to meet product requirements and specifications.
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.
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.
Follow and support the Company’s confidentiality obligations and maintain protection of the Company’s and customers’ proprietary information.