Quality Engineer

* NO Third-party vendors please.

* Must be able to work onsite full time.

* Must be able to work on a Permanent W2 basis (no sponsor ships or Visa transfers)

* Qualified candidates will be contacted immediately.

We’re seeking a skilled Quality Engineer to support validation activities, change control, CAPA, and quality event management within an FDA‑regulated manufacturing environment. You’ll collaborate closely with the Quality Manager, participate in internal and customer audits, and ensure compliance with GMP and regulatory standards.

• Lead equipment, process, and cleaning validation activities (IQ/OQ/PQ), capability studies, and revalidation assessments.
• Maintain the master validation plan; develop and execute qualification protocols.
• Create, update, and review Master Manufacturing Batch Records; manage change control.
• Review completed batch records and address discrepancies.
• Support CAPA investigations, quality events, and customer complaint/OOS investigations.
• Prepare reports, data summaries, charts, and documentation.
• Participate in internal and customer meetings; represent the company during audits and vendor visits.
• Perform other quality‑related duties as assigned.

• Ability to interpret FDA, ISO 13485, and EPA regulations.
• Strong documentation, communication, and presentation skills.
• Proficiency in Microsoft Office;
  Minitab preferred.
• Knowledge of GMP and validation processes (SAT/IQ/OQ/PQ).
• Excellent attention to detail, organization, and problem‑solving skills.
• Ability to work independently and collaboratively in a fast‑paced environment.

• Bachelor’s degree in Engineering or related field.
• 3+ years in medical device or pharmaceutical manufacturing quality.
• Background in science, chemistry, or microbiology lab environments.
• CQE, CQA, Six Sigma, or Lean certifications are a plus.