Katalyst CRO ยท 1 month ago
Medical Device Quality Engineer
Devens, MA
Contract
Onsite
Senior Level, Lead/Staff
10+ years expKatalyst CRO is 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.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
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
Qualification
Required
10+ years of experience in process validation (medical device experience required; not pharma)
Hands-on experience with IQ, OQ, PQ and FMEAs
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
Preferred
Orthopedic device experience preferred
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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