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??????????????????????????????? Deliver key improvements in Quality, Service, and Cost through structured engineering initiatives.
Act as technical lead on product and process issues and drive root cause analysis.
Drive process validation activities: IQ, OQ, PQ, VP, Gauge R&R, etc.
Develop SOPs, work instructions, and documentation aligned to GMP.
Lead cross-functional Continuous Improvement Programs (CIP).
Transfer processes across facilities and support New Product Introduction (NPI).
Provide engineering mentorship to technicians, operators, and engineers.
Lead Value Stream and Cross-Functional Projects as assigned.
Support audit readiness as a Subject Matter Expert (SME).
Ensure strict adherence to EHS and Quality Management Systems (QMS).
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??????????????????????????? Level 8 Degree in Mechanical Engineering or related field.
24 years of experience in a regulated manufacturing environment (preferably MedTech).
Proven Project Management capabilities.
Hands-on experience in Process Validation and Problem Solving (Six Sigma).
Strong documentation and communication skills.
Autonomous, driven, and collaborative mindset.
Excellent leadership, decision-making, and influencing abilities.
Skills: Manufacturing engineering IQ OQ PQ VP GMP