Senior Operations Quality Manager.

4 weeks ago


Singapur, Singapore Medtronic Full time

Careers that Change Lives


We are a learning culture. An inventive and collaborative group. We are dedicated to making sure that every patient gets the best product — when they need it. We have strong ties to our local communities. Our vibrant employee communities respect and value individual experience and perspective as we aim to improve lives and the access to healthcare.


A Day in the Life

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.


Must Have

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


Your Profile

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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