Medical Device Quality Engineer Job at Katalyst HealthCares and Life Sciences, Devens, MA

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  • Katalyst HealthCares and Life Sciences
  • Devens, MA

Job Description

Summary :
Seeking an experienced Medical Device Quality Engineer to support the launch of a new product into production. The role focuses on process validation and ensuring compliance with medical device quality and regulatory standards.
Location: Devens, MA (Onsite, 5 days/week).

Roles & Responsibilities :
  • Develop and execute process validation plans, protocols, and reports for new and existing manufacturing processes.
  • Lead PFMEA sessions to identify, assess, and mitigate process and product risks.
  • Design, validate, and verify test methods to ensure product quality and regulatory compliance.
  • Perform and analyze IQ, OQ, PQ qualifications and other validation activities.
  • Collaborate with cross-functional teams (Quality, Engineering, Manufacturing) to drive continuous improvement and resolve production issues.
  • Analyze validation data and recommend process optimizations based on findings.
  • Write and maintain SOPs, work instructions, and process documentation to support repeatable, high-quality production and regulatory audits.
  • Maintain validation and quality documentation in accordance with internal procedures and applicable regulatory requirements.

Education & Experience :

  • 10+ years of experience in process validation (medical device experience required; not pharma).
  • Hands-on experience with IQ, OQ, PQ and FMEAs.
  • Orthopedic device experience preferred.
  • Strong understanding of regulatory compliance and quality standards applicable to medical devices.
  • Proven ability to develop validation protocols/reports and maintain controlled documentation.
  • Self-starter with excellent problem-solving skills.
  • Ability to work independently and collaboratively in a fast-paced manufacturing environment.

Job Tags

Full time,

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