Quality Manager | Medical Device Manufacturing

My client is an electro-mechanical manufacturer for the medical device industry and they are looking for a Quality Assurance Manager to manage the FDA and ISO Quality Management System and ensure products are designed, developed, manufactured, tested, and delivered to ensure customer and regulatory requirements are met.

Client Details

My client is medical device manufacturer specializing in electro-mechanical manufacturing processes. They are a growing organization as they are launching a brand new product line in which you will heavily support in your day-to-day responsibilities. They are ISO 13485 certified and their products and services are found in almost 50 countries. They offer an opportunity to make a meaningful impact on people's lives.

Description

• Maintain and document quality systems to ensure alignment with ISO, FDA, MDSAP, and other applicable regulatory standards.
• Provide support for Design Control and Product Development, including:
  • Contributing as a cross‑functional team member to enhance product and process designs
  • Coordinating and supporting verification activities and test protocols for new product introductions and design modifications
  • Managing and updating Design History Files (DHF) and Device Master Records (DMR)
• Coordinate and/or support Supplier Quality Management, including:
  • Overseeing the review and release of contract‑manufactured products
  • Evaluating trends and data related to complaints, supplier performance, and nonconforming materials
  • Conducting complaint investigations
  • Monitoring corrective action implementation and verifying effectiveness
  • Performing supplier audits
• Coordinate and/or support Risk Management activities, including:
  • Leading risk assessments such as Failure Modes and Effects Analysis (FMEA) and implementing appropriate risk controls
  • Maintaining Risk Management Files for assigned device families

Profile

• Bachelor's Degree (Engineering-related preferred)
• 7+ years of manufacturing experience within quality
• Understanding of ISO 9001, ISO 13485, and FDA
• Experience with electronic and/or mechanical manufacturing
• Design control experience (design reviews, verifications, validations, DFMEAs, design history files, etc.)
• Understanding of ISO 14971 and UL 60601 is preferred
• ASQ certifications are preferred
• Six Sigma belt is preferred

Job Offer

• Base salary between $120,000 - $150,000
• 15% bonus
• Health, dental, vision
• 401(k) matching
• 3 weeks PTO
• Opportunity for a hybrid work flexibility

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.