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. Requirements: + years of experience in process validation.
Medical Device experience.
Orthopaedic experience preferred.
Expertise in FMEAs and IQ, OQ, PQ validation.
Strong un...