Medical Product Quality Engineer

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