Quality Systems Manager

**Careers That Change Lives**

**Bold thinking. Bolder actions. We are Medtronic.**
People-centered, data-driven. We’re solving the world’s biggest health challenges with healthcare technology. Our Mission, to alleviate pain, restore health, and extend life: unites a global team of 90,000+ passionate people. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we bring groundbreaking healthcare technology solutions for more people in more places around the world

As **Quality Systems Manager **, you will lead initial set up Quality Systems of company entity to meet local medical device regulations and China Good Manufacturing Practices. You are responsible to ensure products manufactured by contract manufacturer meet all defined specifications and are developed and manufactured in compliance with all applicable quality system requirements. You need to provide leadership to work with different Medtronic entities to set up the strong relationship to support the implementation of Quality Systems of company entity in implementing China localization strategy.

**A DAY IN THE LIFE**:
Responsibility:

- Set up the Quality Systems to meet Singapore, China and other countries requirement.
- Establishes quality programs and initiatives to ensure products and assemblies are developed and manufactured per applicable requirements.
- Establish strong supplier control and Quality oversight over suppliers and Medtronic entities.
- Driving continual and preventive improvement of quality management systems in supporting the conformity of process and product quality.
- Supports and develops systems for the identification, analysis, correction, and prevention of quality issues.
- Contributes quality expertise to product development and manufacturing transfers including working closely with suppliers to implement robust manufacturing processes and Quality oversight.
- Oversees and lead key quality systems processes to ensure its effectiveness which includes Design Control, Supplier Controls, Quality Planning, Document Controls, Training, Audits, Change Controls, Nonconformance CAPA, Manage External Requirement, etc.
- Leads the site audit readiness and manages, conducts and coordinates external (Singapore, China, ISO, etc.) audits.
- Take preventive actions to improve the compliance and effectiveness of Quality Management Systems by proactive learning from other sites and best practices from the industry.
- Provides QA support, participate and collaborate with Operating Units improvement program
- Works with local management team members in developing long and short-term quality goals and strategies.
- CAPA board member
- Participate in CAPA and board meetings to review the trending of all input sources and determine if any further action is needed
- Perform review on the CAPA investigation, action plan and effectiveness to determine if CAPA process requirement are fulfilled.
- Represents the new entities to collaborate with peers across all Operating Units for global quality initiatives and works closely with peers on similar quality concerns between Medtronic sites
- Bachelor or Master Degree in Engineering or Science with relevant experience
- Minimum of 5 management expertise in the Pharmaceutical, Medical Devices or any highly regulated commercial Quality and manufacturing industry.
- Familiar with Singapore medical device requirement, China Good Manufacturing practices, ISO13485 and knowledge of Quality System Regulations.
- Effective interpersonal, communication and influencing skills
- Effective listening and writing/technical skills
- Training in the following will be advantaged:

- Singapore HSA (Health Science Authority)
- ISO Standards
- Basic Statistics
- Quality Auditing
- Continuous Quality Improvement Methods
- China GMP

Your vaccination status shall be collected during the interview and selection process referencing and in line with the Safe Management Measures at the workplace stipulated by the Ministry of Manpower

**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.