Senior Compliance Engineering position, responsible for quality and medical industry compliance for UCT.
Essential Duties and Responsibilities:
- ISO 13485 Corporate owner, project manager for extending single site registration and compliance programs to other sites.
- Focal point for the company's registration.
- Responsible for FDA 820 Part 11 compliance and for ISO 13485 compliance.
- Be the Risk management focal, responsible for managing internal audit compliance, scheduling, leading, follow up and closure on all audit actions.
- Be the Compliance focal for New Product Introduction (Quality Engineer) for Medical Products/ Customers.
- Responsible for defining and implementing Production Part Qualification Requirements, Product and Process Validation lead and owner, owner of Risk management plans, results and reports.
- Reports into Site Quality head and supports Medical product Operations team and Medical product Customers.
- First point of contact for medical compliance issues - expected to partner with Manufacturing, various Engineering teams, Purchasing, Supply Chain, Sales, and Operations management.
- Develop, maintain and support Preventive safety and Compliance efforts. Interact at all levels with Customers, Suppliers and all UCT sites across Engineering, Operations, Quality, Customer Service/Support, and management.
Knowledge, Skills and Abilities:
- Demonstrate skill in preventive quality engineering methods and compliance, data analysis, critical thinking, structured problem solving (8D), the use of metrics to identify opportunities, and business process improvement.
- Audit experience in product, process and system audit.
- Strong communication skills.
- Min. of BS in Engineering or equivalent technical discipline is required, Mechanical engineering background is a plus.
- Should be registered ISO 13485 auditor with experience.
- 5-10 years experiences in Compliance Engineering, Operations, Quality & Reliability.
- Experience in quality and manufacturing systems, business process improvement tools, and problem solving.
- Experience with the ISO 13485 standard is required.
- Experience managing critical customer communication.
- Experience with Lean, 5S, zero defect manufacturing processes, inspection methods and tools.