Senior Quality Engineer — Med Device, Lead CAPA & DHR

Merrimack Manufacturing; Manchester (NH); On-site; USD 110,000 - 140,000; Full time

Job summary

Merrimack Manufacturing, a medical device manufacturer in the Manchester Millyard, seeks a qualified professional to support manufacturing quality operations in a fast-paced, regulated environment, including design verification, design validation, and commercial production.

You will lead the Device History Records reviews, NCR and CAPA investigations, PFMEA and control plans, and IQ/OQ/PV activities, coordinating with Production, Engineering, Materials and Quality to ensure 21 CFR 820 and ISO

Qualifications

• 5+ years of experience in medical device manufacturing within a QMS environment (QC or Engineering).
• Experience with 21 CFR 820 and ISO 13485:2016 compliance.
• Experience with internal and external audits.
• Strong project management and leadership skills.
• Knowledge of CAPA, root cause analysis, and 8D problem solving.
• Excellent written and verbal communication.
• Detail-oriented with high accuracy.

Responsibilities

• Lead device history records (DHR) review and approval.
• Lead NCR and CAPA investigations.
• Develop PFMEAs and control plans.
• Lead IQ, OQ, PQ/PV, TMV validation activities.
• Drive manufacturing and quality system improvements.
• Coordinate with cross-functional teams on design changes and risk management.
• Facilitate customer feedback investigations and audits.

Skills

Quality management

Regulatory compliance

Project management

Audits

Data analysis

Education

Bachelor's degree in Manufacturing/Mechanical or life sciences

Tools

Microsoft Office

Minitab

Job description

Merrimack Manufacturing, a medical device manufacturer in the Manchester Millyard, seeks a qualified professional to support manufacturing quality operations in a fast-paced, regulated environment, including design verification, design validation, and commercial production.

You will lead the Device History Records reviews, NCR and CAPA investigations, PFMEA and control plans, and IQ/OQ/PV activities, coordinating with Production, Engineering, Materials and Quality to ensure 21 CFR 820 and ISO