- Leads the QA function to ensure quality system development and compliance with FDA's Quality System Regulation, 13485, MDD / EU MDR, and other quality requirements.
- Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.
- Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
- Provides guidance and coaching to all direct reports, includes establishing individual performance & development objectives and plan
- Leads the strategic planning the functional team in driving continual improvement and effectiveness of Quality Operations and Quality Systems.
- Establishes quality programs and initiatives to ensure products and assemblies are developed and manufactured in accord with applicable requirements.
- Leads and/or supports initiatives at Medtronic Singapore and across sites to ensure effective quality reporting, quality systems and quality improvement efforts and Customer-Focused Quality supervise the Quality System implementation. Supports the implementation of engineering projects, including design transfers and provide management oversight in establishing the quality system requirement at other facilities and Medtronic projects.
- Act as the CAPA board chair to ensure effective CAPA process and drive the development of systems and processes for the identification, analysis, correction, and prevention of quality issues.
- Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.
- Works with Singapore and platform leadership team members in developing long and short-term business goals and strategies.
- Represents Singapore on OU/ enterprise Quality Leaders team meeting, collaborate with peers across all sites and Operating Units for global quality initiatives and works closely with peers on similar quality concerns between MDT sites.
- Bachelor's degree required
- Minimum of 7 years of relevant experience with 5+ years of managerial experience, or advanced degree with a minimum of 5 years of relevant experience with 5+ years of managerial experience
- Minimum of 5 to 7 years management expertise in the Pharmaceutical, Medical Devices or any highly regulated manufacturing industry.
- Overall operational and financial acumen, Business and Project Management skills and experience a plus.
- Familiar with Quality System requirement and knowledge of Quality System Regulations and ISO.
- Broad management knowledge to lead a team and have a prior experience in manufacturing environment and Quality function.
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Quality Manager
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RECRUITPEDIA PTE. LTD. Singapore**Our client is a Manufacturing MNC, one of the leading players in the Contract Manufacturing sector. Due to business needs, they are now recruiting a Quality Manager to be part of their Quality team for ongoing transformation projects. They are located in the North - easily acce ...
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International Air Transport Association (IATA) SingaporeEmployment Type: Permanent · Contract Duration: · About the team you are joining · Reporting to the Head, Quality, the Manager, Quality is responsible for the Global Operations Compliance program, the Exception management process and BCP (Business Continuity Plan) program managem ...
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JINYUE ALUMINIUM ENGINEERING (SINGAPORE) PTE. LTD. SingaporeJob Highlights: · Annual Performance Appraisal Assessment · Comprehensive medical insurance · Job Responsibilities: · - Drive the Company's Quality Assurance and Quality Control performance at all construction sites involving QM, Conquas and QMS in terms ISO standards. · - Overse ...
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ByteDance SingaporeAbout ByteDance · Founded in 2012, ByteDance's mission is to inspire creativity and enrich life. With a suite of more than a dozen products, including TikTok, Helo, and Resso, as well as platforms specific to the China market, including Toutiao, Douyin, and Xigua, ByteDance has m ...
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Senior Operations Quality Manager - Singapore - Medtronic Cardiac and Vascular
2 days ago
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