Operational Area Quality Senior Manager (Medtech)

TL;DR

Operational Area Quality Senior Manager (Medtech): Providing quality leadership for assembly manufacturing operations of medical devices and combination products with an accent on regulatory compliance, product disposition, and supplier quality. Focus on leading root cause investigations, managing CAPAs, and ensuring manufacturing changes align with design controls and risk management throughout the product lifecycle.

Location: Boston, MA. Hybrid (up to 2 days remote) or On-Site

Salary: $133,800 - $200,600

Company

Vertex is a global biotechnology company that invests in scientific innovation.

What you will do

• Lead QA support for assembly manufacturing operations, ensuring GMP and regulatory compliance for medical devices.
• Oversee product disposition, including review and approval of MBRs, EBRs, and DHRs to support clinical and commercial release.
• Manage manufacturing deviations, investigations, NCMRs, CAPAs, and change controls using structured problem-solving.
• Partner with Contract Manufacturing Organizations (CMOs) to ensure compliance with Quality Agreements.
• Lead supplier quality activities, including investigations, qualification, and change assessments.
• Support Design Quality activities, risk management (DFMEA, PFMEA), and regulatory inspections.

Requirements

• Bachelor's degree in Engineering, Life Sciences, Quality, Manufacturing, or a related technical discipline.
• 10+ years of experience in QA, Quality Engineering, or Manufacturing Quality within the medical device, biotechnology, or pharmaceutical industry.
• Minimum 5 years supporting GMP manufacturing operations, including assembly and product disposition.
• Proven experience with autoinjectors, prefilled syringes, or other drug-device combination products.
• Strong knowledge of GMP, 21 CFR Part 820, 21 CFR Part 4, ISO 13485, and ISO 14971.
• Must be based in or able to work in Boston, MA.

Culture & Benefits

• Competitive base salary with eligibility for annual bonus and equity awards.
• Inclusive market-leading benefits including medical, dental, and vision insurance.
• Generous paid time off, including company-wide shutdowns in Summer and Winter.
• Educational assistance programs including student loan repayment.
• Commuting subsidy and 401(k) matching.