Quality Systems Manager

**Careers That Change Lives**

**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.**

**Our Purpose**

Founded in 1949, our **Mission **continues to serve as our ethical framework and inspirational goal for our employees around the world. It guides our day-to-day work and reminds us that our efforts are **transforming the lives **of millions of people each year. If you have a passion for medical device manufacturing, this opportunity could be for you

**Quality Systems Manager**

**A Day in the Life**
- Leads the Quality System development and deployment in the Medtronic Singapore Operations (MSO) facilities.
- Ensures products manufactured in MSO meet all defined specifications and are developed and manufactured in compliance with all applicable quality system requirements.
- Provides leadership and support for Customer Focused Quality, Quality Engineering and Quality System improvement initiatives.
- Function as the key regulatory contact for Manufacturing Operations.

Key Responsibilities:

- Leads the QS function to ensure quality system development and compliance with FDA's Quality System Regulation, ISO 9001, ISO 13485/8, MDD, CMDR, Japan R- PAL and other quality requirements.
- Establishes quality programs and initiatives to ensure products and assemblies are developed and manufactured in accord with applicable requirements.
- Leads and/or supports initiatives to ensure effective quality reporting, quality systems and quality improvement efforts and Customer-Focused Quality; supervise the Quality System Policy/Procedures Manual.
- Support the quality planning process and overseeing the performance and effectiveness of Quality Management Systems.
- 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 initiatives to ensure effective compliance to the Product Development Protocol and other applicable requirements.
- Oversees and lead key quality systems processes to ensure its effectiveness which includes Quality Planning, Document Controls, Training, Audits, Change Controls, Nonconformance CAPA, Manage External Requirement, etc.
- Leads the MSO site audit readiness and manages, conducts and coordinates external (FDA, TUV, 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.
- Manages the design and manufacturing documentation and traceability systems.
- Provides QA support, participate and collaborate in division related projects.
- 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 MSO on Global Quality Leaders Council, collaborate with peers across all BUs for global quality initiatives and works closely with peers on similar quality concerns between MDT sites.

**Must Have: Minimum Requirements**
- Bachelors degree required
- Minimum of 5 years of relevant experience, or advanced degree with a minimum of 3 years of relevant experience

**Nice to Have**
- Preferably with 6 years of management expertise in the Medical Devices, Pharmaceutical or any highly regulated manufacturing industry.
- Overall operational and financial acumen, Business and Project Management skills and experience a plus.
- Familiar with Quality System Regulation, MDD, and knowledge of Quality System Regulations and ISO.
- Training in the following will be advantaged: ISO Standards, Basic Statistics, Quality Auditing, Continuous Quality Improvement Methods, GMP
- Effective interpersonal, communication and influencing skills
- Effective listening and writing/technical skills

**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 h