APAC Principal Quality Engineer- Healthcare & Medical
Responsibility:
61 Implement TSS China ISO 13485 internal audit, QMR, NCE/CAPA, Risk assessment, coordinate notified body audit as per TMS global policy.
61 Provides training to APAC TMS staffs regrading TMS Document/Record Control requirements and Dot compliance system modules.
61 Review all APAC documentation in Dot Compliance system as Document control role.
61 Supports Purchasing and New Product Department in supplier selection, either by identifying existing approved suppliers or new suppliers
61 Evaluate and approve TSS/Third Party Suppliers, route ASL update in Dot compliance.
61 Complete TSS/3rd Party supplier quality and change notice agreements, NDA, and other documents per procedure.
61 Develops and maintains the annual supplier audit plan. Schedules, prepares and conducts supplier site audits to determine the state of a potential supplier’s quality system in relation to ISO 13485, ISO 9001.
61 Evaluate 3rd Party Supplier proposed changes as per supplier change control process.
61 Reviews and implements Supplier Quality Agreements and Change Agreements
61 Supports Engineering and Inspection groups in analysis of incoming material defects
61 Reviews supplier performance data and participates in the Supplier Score Card process
61 Tracks, analyzes, and reports on supplier performance to management and other team members as necessary.
61 Manages all nonconformances related to Supplier Quality processes
61 Coordinates with suppliers and identifies areas for supplier quality improvements
61 Ensures supplier audit findings are tracked to timely and adequate closure.
61 Supports all necessary site audits (internal and external) as related to Supplier Management
61 Develops ideas and strategies to improve operational efficiency, add value, aid business performance and work towards a culture of continuous improvement
61 Coordinate the customer audit and finding response.
61 Review and filing customer quality agreements as per TMS policy
61 Provide quality inputs for any customer survey/questionaires.
61 Work with TSS/3rd party suppliers to resolve customer complaints, document resolution in Dot compliance.
61 Coordinate customer product disposition requests with suppliers, issue MRB in Dot compliance
61 Other duties as assigned
Requirements:
Required:
61 Advanced degree in Engineering or related field
61 Lead Auditing experience related to ISO 13485 and Medical Device GMP.
61 10+ years of in medical device industry.
Desired:
61 Certified Supplier Quality Engineer/ Auditor
61 Experience in coaching and utilizing performance management tools and disciplines.
61 Leadership/Supervisory experience with decision making authority/responsibility
61 Certified Six Sigma Black Belt