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 memberParticipate 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
