Medical Device Quality Engineer

📍 Location: Devens, MA
💰 Pay Rate: $80-$90/hr W2 (Negotiable) + Benefits
🗓 Start Date: December 2025
📅 Duration: 6 months to Hire!
🏢 Work Arrangement: Onsite, 5 days/week

About the Role

We are seeking an experienced Medical Device Quality Engineer to support the launch of a new product into production. This role focuses on process validation and ensuring compliance with industry standards for medical devices.

Key Responsibilities

• Develop and execute process validation plans, protocols, and reports for new and existing manufacturing processes.
• Lead PFMEA sessions to identify and mitigate risks.
• Design and validate test methods to ensure product quality and regulatory compliance.
• Collaborate with cross-functional teams (Quality, Engineering, Manufacturing) to drive continuous improvement.
• Analyze validation data and recommend process optimizations.
• Maintain documentation in line with internal procedures and regulatory requirements.
• Write and maintain SOPs, work instructions, and process documentation for repeatable, high-quality production.

Must-Have Qualifications

• 10+ years of experience in process validation.
• Medical Device experience (NOT Pharma).
• Orthopedic experience preferred.
• Expertise in FMEAs and IQ, OQ, PQ validation.
• Strong understanding of regulatory compliance and quality standards.

Soft Skills

• Self-starter with excellent problem-solving skills.
• Ability to work independently and collaboratively in a fast-paced environment.

Additional Details

• Candidate Type: W2 or 1099 (US Citizens only).
• Interview Process: Direct with hiring manager; quick turnaround if resume is a fit.

👉 Interested? Apply now and help bring innovative medical devices to life!

Impellam Group and its brands are equal-opportunity employers committed to diversity and inclusion. All qualified applicants will receive consideration without regard to race, color, religion, gender, sexual orientation, pregnancy or maternity, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application, interview process, pre-employment activity, and the performance of crucial job functions.

If you require additional disability considerations, modifications, or adjustments please let us know by contacting HR-InfoImpellamNA@impellam.com or fill out this form to request accommodations.