研发质量工程师-医疗器械

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
Bachelor or master degree in engineering- mechanical, electrical, industrial.
Certified 6 sigma green belt preferred.
3 - 10 years related work experience, in a medical device area, or equivalent.
Experience in product design quality or manufacturing quality management.
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)