Quality Engineer- Medical Device- Milford, Ma

Exciting opportunity for a Quality Engineer to develop and implement quality plans, programs, and procedures using lean manufacturing principles and quality control statistics. This role involves investigating quality discrepancies, implementing corrective actions, performing audits, and collaborating with cross-functional teams to ensure compliance with the Quality Management System.

Client Details

Global leader in designing and manufacturing precision medical components, this company specializes in cannulated cutting tools, nitinol instruments, PTFE-coated mandrels, and high-quality wires and drills for orthopedic and interventional applications. Renowned for its master grinding expertise and advanced CNC machining capabilities, they deliver unparalleled quality and high-volume production solutions to meet the needs of medical OEMs worldwide.

Description

• Develop and implement ISO 13485-compliant quality policies and procedures.
• Lead investigations for complaints, non-conformances, and CAPAs to drive resolution.
• Create and execute validation protocols for manufacturing processes and products.
• Apply risk analysis techniques, including PFMEA, to enhance quality processes.
• Manage Change Control and supplier/customer notifications effectively.
• Define in-process and incoming inspection requirements to ensure precision.
• Analyze production, customer complaints, and non-conformance data for improvements.
• Demonstrate expertise in blueprint reading, GD&T, and precision inspection tools.
• Utilize project management skills to meet milestones and deliverables.
• Leverage software like Microsoft Project, E2, and MS Office for quality initiatives.
• Collaborate as a team player with a positive attitude and strong communication skills.

Profile

• Bachelor's degree in Engineering or Associate's degree with relevant experience.
• 3+ years of proven experience in Quality Engineering within medical device manufacturing or a regulated industry.
• Skilled at managing multiple projects in a dynamic, fast-paced manufacturing setting.
• Preferred: ASQ certifications (CQE, CQA, or similar).

Job Offer

• Opportunity for Growth: Work in a dynamic, fast-paced environment with the potential for career advancement.
• Professional Development: Access to continuous learning and training in a highly regulated industry.
• Impactful Role: Lead and contribute to critical quality initiatives in medical device manufacturing.
• Competitive Compensation: Competitive salary package commensurate with experience.
• Collaborative Environment: Work alongside a skilled and motivated team to drive quality improvements.
• Hands-On Experience: Engage in real-time, hands-on problem-solving in a manufacturing environment.
• Work-Life Balance: A supportive work culture that values employee well-being and work-life balance.

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.