Quality Assurance Specialist II, Device Engineering
Real · Woburn, MA · 2 wk ago
On-siteQuality AssuranceFull-time
Location: Woburn, MA (relocating to a new facility in Allston next year)
Schedule
Onsite 5 days/week with future hybrid flexibility following relocation
Pay
$85,000 - $105,000 base salary + bonus + stock options
Responsibilities
- Support Quality Assurance activities for combination product programs
- Lead and support Design Control activities, including DHF management, design reviews, and DV&V efforts
- Participate in Risk Management activities, including FMEA and hazard analysis
- Support process validation, equipment qualification, and test method validation activities
- Review GMP documentation, batch records, protocols, reports, and manufacturing records
- Support supplier quality programs, audits, and qualification activities
- Contribute to CAPAs, investigations, nonconformance management, and continuous improvement initiatives
- Ensure compliance with ISO 13485, FDA Quality System Regulations (21 CFR 820), and combination product requirements
Requirements
- 4+ years of quality experience within medical devices, combination products, pharmaceuticals, or biologics
- Strong knowledge of ISO 13485 and FDA Quality System Regulations (21 CFR 820)
- Experience with Design Controls, Design History Files (DHFs), and Design Verification & Validation (DV&V)
- Experience with Risk Management and FMEA
- Validation experience (process, equipment, and/or test methods)
- GMP documentation review experience
- Strong communication and technical writing skills
Benefits
- Competitive compensation package including bonus and equity
- Medical, dental, and vision coverage
- Paid leave where required by applicable law
About the role
- Innovative technology platform with significant clinical potential
- Direct exposure to cross-functional teams and leadership
- Opportunity to make a meaningful impact during clinical development and commercialization