Regional Quality Systems Liaison
Teleflex
- Kulim, Kedah
- Permanent
- Full-time
- Provide regional support for the 1QMS and eQMS strategic initiatives.
- Serve as the key change agent in the region, communicating the project vision.
- Provide input/review training content for global roll out of harmonized QMS processes to ensure accessibility.
- Support translations of QMS documents and training as needed.
- Serve as the voice of 1QMS and eQMS in for facilities in the region, supporting training efforts, communications, gap assessment activities with local procedures, and change management activities.
- Lead change management activities within the region for 1QMS and eQMS.
- Work with local change analysists at facilities within the region to implement new and revised processes.
- Create a closed loop system to ensure consistent implementation across the organization.
- Assist in gap assessment activities with local procedures, escalating concerns from the facilities to the 1QMS team.
- Lead or support additional local or global projects as assigned by Quality and Regulatory Leadership.
- B.A. or B.S. degree in a technical discipline, such as engineering or science (equivalent experience may be considered).
- 2 to 5 years of experience in quality or compliance (preferably in the medical device industry).
- Basic understanding of industry regulations such as ISO 13485, ISO 14971 and FDA 21CFR820.
- Proficient in MS Office.
- Strong organizational and time management skills to meet deadlines while managing multiple projects.
- Strong analytical and critical thinking skills.
- Proficient in technical writing and review.
- Strong verbal and written communication skills.
- Foster a positive culture of growth, collaboration, and achievement across the organization.