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Quality Validation Engineer

Intellectt INC

  • NULL, MA
  • 7 days ago
  • $45–$49

Highlights

5+ years of Quality Engineering or Validation Engineering experience, preferably in medical devices, pharmaceuticals, or regulated manufacturing. Coordinate with Engineering, Manufacturing, Quality, and project teams to meet equipment transfer timelines and escalate issues.

Numbers & Facts

LocationNULL, MA
Salary$45–$49

Description

Job Title: Quality Validation Engineer
Location: Danvers, MA (100% Onsite)
Employment Type: Contract

Duration- 12 months

Job Responsibilities

  • Lead equipment transfer and Business Continuity Planning (BCP) validation activities from planning through execution and closeout.

  • Develop and execute IQ/OQ/PQ, process validation, equipment qualification, and Gauge R&R studies.

  • Requalify transferred manufacturing equipment and verify readiness for production use.

  • Support validation of manufacturing machinery, benches/workstations, gauges, laser equipment, and other production assets.

  • Investigate testing discrepancies, troubleshoot equipment issues, and maintain complete validation documentation.

  • Coordinate with Engineering, Manufacturing, Quality, and project teams to meet equipment transfer timelines and escalate issues.

Required Qualifications

  • 5+ years of Quality Engineering or Validation Engineering experience, preferably in medical devices, pharmaceuticals, or regulated manufacturing.

  • Strong hands-on experience developing, executing, and closing IQ/OQ/PQ and process validation protocols.

  • Experience with equipment qualification and Gauge R&R / measurement system analysis.

  • Ability to independently manage validation deliverables with limited oversight.

  • Strong troubleshooting, documentation, communication, and cross-functional coordination skills.

  • Availability to work onsite in Danvers and surrounding facilities.

  • Medical device manufacturing, equipment relocation, site transfer, BCP, or FDA remediation experience preferred.

  • Previous J&J / Abiomed experience is a plus.

Pay Scale

Anticipated hourly pay range: $45/hr $49/hr on W2, depending on experience.

Benefits

Employees hired into this position are eligible for the following benefits, subject to applicable plan terms and eligibility requirements:

Health Insurance: Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for paying the full cost of their insurance premiums.

Retirement Benefits: A 401(k) retirement savings plan is available. No employer matching or other employer contributions are provided.

Paid Time Off (PTO): No PTO other than that required by applicable state and local laws.

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