Quality Assurance Specialist II, Device Engineering

Quality Assurance Specialist II, Device Engineering

Location: Woburn, MA (relocating to a new facility in Allston next year)

Schedule: Onsite 5 days/week with future hybrid flexibility following relocation

Compensation: $85,000 - $105,000 base salary + bonus + stock options

Join an innovative team developing a breakthrough drug delivery platform with the potential to transform how vaccines and therapeutics reach patients around the world.

• 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

• 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

• Innovative technology platform with significant clinical potential
• Competitive compensation package including bonus and equity
• Direct exposure to cross-functional teams and leadership
• Opportunity to make a meaningful impact during clinical development and commercialization

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

In addition to base pay, direct-hire employees may be eligible for client offered benefits such as medical, dental, and vision coverage, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change.