Quality Validation Engineer

Novozen Healthcare LLC; Massachusetts; On-site; USD 62,000 - 68,000; Full time

Benefits offered by this job

Health Insurance

401(k) retirement savings plan

Job summary

Novozen Healthcare LLC is seeking a seasoned Quality/Validation Engineer for an approximately 12-month contract on-site in Danvers, MA. You will lead equipment transfer, plan and execute IQ/OQ/PQ, validate processes, qualify equipment, and perform Gauge R&R studies.

The role requires strong troubleshooting, documentation, and cross-functional collaboration, with prior experience in medical devices or regulated manufacturing. J&J/Abiomed experience is a plus.

Qualifications

• 5+ years of Quality Engineering or Validation Engineering experience in medical devices or regulated manufacturing.
• Hands-on experience developing, executing, and closing IQ/OQ/PQ and process validation protocols.
• Experience with equipment qualification and Gauge R&R / MSA.
• 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.
• Preferred: experience with J&J / Abiomed.
• Experience in medical device manufacturing, equipment relocation, site transfer, BCP, or FDA remediation is a plus.

Responsibilities

• Lead equipment transfer and 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 validation documentation.
• Coordinate with Engineering, Manufacturing, Quality, and project teams to meet equipment transfer timelines and elevate issues.

Skills

Quality engineering

Validation engineering

IQ/OQ/PQ execution

Process validation

Equipment qualification

Gauge R&R / MSA

Documentation

Cross-functional coordination

Job description

Employment Type: Contract — Approximately 12 months, with potential for extension

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 elevate 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–$49/hr on W2, depending on experience.

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.