More jobs:
Quality Engineer
Job in
Ayer, Middlesex County, Massachusetts, 01432, USA
Listed on 2025-12-08
Listing for:
Katalyst CRO
Full Time
position Listed on 2025-12-08
Job specializations:
-
Engineering
Quality Engineering, Process Engineer
Job Description & How to Apply Below
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Roles & Responsibilities- Develop and execute process validation plans, protocols, and reports for new and existing manufacturing processes.
- Lead PFMEA sessions to identify and mitigate risks.
- Design and validate test methods to ensure product quality and regulatory compliance.
- Collaborate with cross-functional teams (Quality, Engineering, Manufacturing) to drive continuous improvement.
- Analyze validation data and recommend process optimizations.
- Maintain documentation in line with internal procedures and regulatory requirements.
- Write and maintain SOPs, work instructions, and process documentation for repeatable, high-quality production.
- 10+ years of experience in process validation.
- Medical Device experience.
- Orthopaedic experience preferred.
- Expertise in FMEAs and IQ, OQ, PQ validation.
- Strong understanding of regulatory compliance and quality standards.
- Self‑starter with excellent problem‑solving skills.
- Ability to work independently and collaboratively in a fast‑paced environment.
- Mid‑Senior level
- Contract
- Quality Assurance
- Pharmaceutical Manufacturing
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