Supplier Quality Engineer — Medical Devices (ISO 13485/FDA)

Merrimack Manufacturing; Manchester (NH); On-site; USD 65,000 - 85,000; Full time

Job summary

Merrimack Manufacturing in Manchester NH is seeking a Quality Assurance specialist to support supplier quality and ensure compliance with ISO 13485 and FDA requirements for our medical devices. You will partner with Incoming Inspection, Engineering and Material Management to drive NCR dispositions, supplier corrective actions, and continuous improvement across the product lifecycle.

This role emphasizes data analysis, documentation accuracy, and cross-functional collaboration to prevent quality

Qualifications

• 2+ years of experience in a Quality Assurance role, or with a medical device manufacturing company.
• Certified quality auditor experience is a plus.
• Familiarity with ISO 13485:2016 and FDA 21 CFR Part 820.
• Detail-oriented with strong verbal and written communications skills; demonstrated ability to manage multiple projects.

Responsibilities

• Assist inspection with evaluating cosmetic specifications and other intricate component requirements requesting input and communication with QE/ME as needed.
• Interface with Incoming Inspection, discuss results, document disposition and required approvals to ensure timely closure of Nonconformance Reports.
• Serve as key contributor at weekly Incoming Inspection NCR MRB meeting.
• Utilize relationships with MMC incoming inspection group and the supplier to investigate differences between measurements.
• Communicate failures to suppliers, request SCARs where necessary and document effectiveness of corrective actions.
• Work with Supply Chain to attain RMA numbers, ensure dispositions are carried out per NCR approval.
• Generate and Distribute Scorecards to suppliers
• Conduct ASL updates in MMC PLM system for new suppliers, Supplier Change Notifications etc.
• Interface with suppliers, Manufacturing Engineers and Quality Engineers to evaluate potential component issues. Walk down MMC processes vs supplier processes and determine root cause.
• Work with Supplier Development and Sr. SQE to schedule telecons, investigate process control issues or breakdowns, identify high-risk suppliers, schedule for cause audits, etc.
• Facilitate the review and approval of supplier-initiated changes requests, and communicate the approved changes through Quality and to the appropriate departments.
• Look for opportunities to drive preventive actions and continuous process improvement with our suppliers.
• Assist as needed with customer audits and regulatory audits.
• Provide recommendations for improvements and help drive best practices to SOPs pertinent to QA GMP Compliance activities.

Skills

Quality assurance

Auditing

Cross-functional teams

Data analysis

CAD interpretation

MS Office

Travel readiness

Education

Bachelor’s in Engineering or related experience

Tools

CAD software

Job description

Merrimack Manufacturing in Manchester NH is seeking a Quality Assurance specialist to support supplier quality and ensure compliance with ISO 13485 and FDA requirements for our medical devices. You will partner with Incoming Inspection, Engineering and Material Management to drive NCR dispositions, supplier corrective actions, and continuous improvement across the product lifecycle.

This role emphasizes data analysis, documentation accuracy, and cross-functional collaboration to prevent quality