Quality Engineer

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• 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