Senior Quality Engineer - Combination Product

Overview

Senior Quality Engineer - Combination Products
On site - Massachusetts
$90,000 to $120,000 DOE

Elevate the quality of life changing combination therapies. Step into a senior role where your decisions directly protect patients and shape how drug‑device products are designed, built and released in a rigorously regulated cGMP, ISO 13485, and 21 CFR 820 / 210 / 211 environment.

• Own site level quality for your value streams: CAPA, NCs/NCRs, SCARs, and investigations for combination products.
• Decide what ships: you have the authority to stop nonconforming product entering manufacturing or reaching patients.
• Strengthen and evolve the QMS to meet and exceed ISO 13485, 21 CFR 820, and applicable drug regulations for combination products.
• Lead internal and supplier audits and be a key player in customer, notified body and FDA inspections.
• Act as the go to SME for at least one area (e.g. validation, complaints, NCs, CAPA) and upskill engineers and inspectors around you.
• Represent Quality with customers on SCARs, complaints, audit reports and change notifications for combination product lines.

• Bachelor's degree in engineering or a related technical field.
• 5+ years' quality engineering experience in combination products (drug-device) within a regulated manufacturing environment.
• Proven experience with:
• ISO 13485 and 21 CFR 820, plus hands on work under 21 CFR 210/211 for combination products.
• CAPA leadership, internal/supplier audits, and supplier quality management.
• Process validation (IQ/OQ/PQ) and statistical tools (e.g. Minitab, capability, GR&R, control charts).
• Risk management tools such as pFMEA.

Benefits include 401k, family health plan, 30 days PTO, on site wellness perks and more.

If you want ownership, visibility, and a direct line of sight from your quality decisions to patient outcomes in complex combination products, this role is built for you.

No sponsorship available.