Quality Engineer

Description

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, Zimmer Biomet, 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.

MAIN RESPONSIBILITIES:

• Represent the Quality function during new Product Development Process and Design Reviews.

• 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.

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 time including some limited international travel, is required.