Quality Systems Manager

**Careers That Change Lives:
**This role will lead initial set up of Quality Systems for a new entity to meet local medical device regulations and China Good Manufacturing Practices.

**A Day In The Life:
**This role will Ensure products manufactured by contract manufacturer meet all defined specifications and are developed and manufactured in compliance with all applicable quality system requirements and provide leadership to work with different Medtronic entities and set up the strong relationship to support the implementation of Quality Systems for the new entity in implementing China localization strategy.

**Primary Responsibilities**
- Set up the Quality Systems to it meets Singapore, China and requirement 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

**Must Haves**
- Bachelors Degree required Minimum of 5 years of relevant experience, or advanced degree with a minimum of 3 years of relevant experience

**Your Profile**:

- 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.
- Training in the following will be advantaged:

- Singapore HSA (Health Science Authority)
- ISO Standards
- Basic Statistics
- Quality Auditing
- Continuous Quality Improvement Methods
- China GMP
- Effective interpersonal, communication and influencing skills Effective listening and writing/technical skills

**About Medtronic Singapore Operations
**Medtronic Singapore Operations was among the first international medical technology firms to set up manufacturing operations in Singapore. We are one of the most advanced medical device manufacturing sites and the first manufacturing facility of its kind in the region to make implantable cardiac leads, pacemakers and monitors. As a company Medtronic is intensely focused on creating a workplace environment which reflects our standing as the world’s top medical device company.

**What We Offer
**We recognize the personal worth of employees by providing an employment framework that allows personal satisfaction in work accomplished, security, advancement opportunity, and means to share in the company's success. We believe in rewarding our staff with a complete package of benefits designed to support them at every career and life stage. As a result, our employees have access to the following benefits, to name a few:

- Our global well-being program supports your physical, emotional, social and financial well-being.
- Medtronic Employee Assistance Program offers confidential support and resources to build and enhance employee and organizational resilience, productivity, teamwork and psychologically healthy workplaces.
- Various insurance benefits include Inpatient and Outpatient Medical Insurance, Life, Disability and Accident Insurance. We have generous employee referral programs, employees stock purchase plan, leave benefits, and more

**Physical Job Requirements
**The above statements are intended to describe