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.
Qualifications
Must Have
- Requires a Bachelor’s degree minimum of 5 years relevant experience, or advanced degree with a minimum of 3 years prior relevant 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.
About Medtronic
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.
We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.
Physical Job Requirements
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.
