质量体系管理ISO13485 KEY RESPONSIBILITIES/TASKS/ 主要职责/任务
 Provide leadership in design & device implementation to support entire product life cycle of various products with focus on Quality Engineering activities such as reliability, risk management, analytics/statistical techniques, requirements management, verification & validation, and design control.
 Apply tools and methods (for example: Six Sigma, Lean) to realize new product or process introductions as well as process and business improvements.
 Provide leadership and technical expertise to ensure conformance to ISO, FDA & MDR based quality systems.
 Review and approve the release of new products and design changes ensuring quality requirements are met.
 Direct development & consistent application of quality policies & procedures in product design & development, secondary development & transfer operations.
 Act as technical liaison between product development, manufacturing, external manufacturers & suppliers.
 Use analytical problem-solving skills for root cause investigations.
 Use sound statistical applications in areas such as DOE, sampling techniques, regression, reliability, FMEA, hypothesis testing, etc.
 TRAVEL REQUIREMENTS: Moderate travel may be required
Required:
 Intermediate knowledge of Quality Engineering/Scientific methods and techniques
 Experience with Risk Management Tool: FMEA and Quality Management Systems (ISO 9001).
 Knowledge of test method development, applied statistics and reliability.
 Project management (supporting multiple projects at a time)
 Experience with Quality System processes (CAPA, NCR, Risk Management, Design Control, Change Control)
 Fundamental technical understanding of manufacturing equipment and processes.
 Able to identify and simplify sophisticated issues, as well as demonstrate ability for proactive, organized, and systemic approach to decision making and resolving issues
 Able to work in a team and demonstrate good interpersonal, organization, and oral/written communication skills in English.
Preferred:
 Experience in medical device or other highly regulated industry; military veteran leadership experience is an asset.
 Familiarity with medical device regulations (FDA, EU-MDR, NMPA etc.)
 Experience with Risk Management (ISO 14971) and Medical Device Quality Management Systems (ISO 13485).
 Quality Engineering Certification (e.g., ASQ CQE) and/or Process Excellence Certification (e.g. Green Belt)