Medical Product Quality Engineer

Website TRIAD Engineering Corp

Our client is seeking a Quality Engineer to be a hands-on resource in implementing ISO 13485 quality processes in their additive manufacturing plant northwest of Boston, MA.

Medical Product Quality Engineer Responsibilities will include:

• Ensure the IQ, OQ, and PQ process meets customer expectations and supports our client’s Quality Management System.
• Assist the Quality Engineering Manager in assuring the QMS conforms to the customer, internal, industry (ISO 13485), and regulatory/legal requirements by conducting audits and identifying gaps.
• Assure inspecting and testing materials, equipment, processes, and products meet quality specifications.
• Collaborate to develop and implement quality and process controls and improvements.
• Assure that calibration methods meet customer requirements and industry standards.
• Investigating and troubleshooting product or production issues
• Lead the inspection of manufactured parts, issue non-conformance reports, and facilitate the disposition of MRB hardware and corrective action tasks.

Medical Product Quality Engineer Background profile:

• Bachelor’s degree in engineering or a related field is required
• 7+ years of experience in medical product development
• 7+ years of experience in Quality Assurance/Quality Control
• Expert knowledge of medical product quality management qualification systems
• Experience in project management of the IQ, OQ, and PQ process
• First Article and inspection method creation
• Ability to complete coordinate calibration systems
• Expert knowledge of IS0 9001:2015 and ISO 13485
• Experience working in ITAR/EAR compliant organization
• Ability to lead and educate a diverse team of technologists
• Root Cause Analysis, Data analysis, and Statistical Process Control
• Strong organizational, analytical, problem-solving, and task-management skills
• Strong sense of ownership
• Team player with excellent communication skills
• Excited about taking on new challenges in the metal additive manufacturing industry and working in a fast-paced startup environment
• Self-motivated, hands-on, with a practical mindset, and capable of setting and reaching ambitious goals

Tagged as: audit, calibration, IQ, ISO 13485, manufacturing, medical device, OQ, PQ, QMS, root cause, SPC

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ByTRIAD Recruiting TeamApr 24, 2023

About the Author:

The TRIAD Recruiting Team is comprised of technical recruiters specializing in the engineering disciplines. TRIAD Engineering Corp. (www.triad-eng.com) is an engineering staffing firm based in Lynnfield, Massachusetts that connects successful firms with technical talent throughout Massachusetts, New Hampshire and Rhode Island. For almost 50 years, TRIAD has provided clients with flexible staffing arrangements including contract, contract-to-direct, and direct placement services.