Quality Engineer - Medical Devices (ISO 13485 / 21 CFR 820)

Job Description

Title: Quality Engineer – Medical Devices (ISO 13485 / 21 CFR 820)

Location: Nashua, NH (100% Onsite)

Shift: 1st Shift

Employment Type: Contract (6 months, strong extension potential)

Status: Accepting Candidates

About the Role

We are supporting a medical device manufacturing organization seeking a Quality Engineer to support new product introduction (NPI) and sustained manufacturing. This role applies quality engineering principles, regulatory standards, and continuous improvement methodologies in a regulated environment, working closely with engineering, manufacturing, and supplier quality teams.

Key Responsibilities

• Support NPI transitions from early-stage development into controlled builds and sustained manufacturing
• Interface with supplier quality organizations to support manufacturing transition and process sustainment
• Serve as a quality representative on product development teams, supporting:
• Design controls
• Validation activities
• Risk management
• Design verification & release
• Post-market quality activities
• Apply Quality Engineering tools and techniques, including:
• Lean Six Sigma problem-solving
• Process Validation & Optimization
• Gage R&R
• Statistical analysis (Minitab or similar)
• Ensure compliance with ISO 13485 and 21 CFR 820
• Create and maintain quality documentation and technical reports
• Support supplier audits and qualification activities as required

Required Qualifications

• Minimum 2 years of experience in Quality Engineering within a medical device manufacturing environment (or equivalent regulated engineering experience)
• Bachelor’s degree or equivalent practical experience
• Hands-on experience with ISO 13485 and 21 CFR Part 820
• Experience creating and maintaining quality documentation
• Working knowledge of statistical tools/software (Minitab preferred)
• Strong technical writing and professional communication skills
• Ability to collaborate effectively with internal teams, customers, and suppliers

Compensation

• Estimated hourly range: $36–$44/hr (W-2)
• Final rate within this range will be based on skills, experience, and interview results