Global Capa Specialist

1 week ago

Hougang, Singapore WS Audiology APAC Full time

Driven by the passion to improve quality of people’s lives, WS Audiology continues to grow as market leader in the hearing aid industry. With our commitment to increase penetration in an underserved hearing care market, we want to accelerate our business transformation in order to reach more people, more effectively.

Join our team as a Global CAPA Specialist and support the global CAPA process as well as being part of the global auditor team with a focus of managing affiliates within the APAC region. Reporting to the Global CAPA Officer, we are looking for a passionate individual with a background in engineering with experience in CAPA and auditing within the medical device or medical technology industry.

**What you will do**:

- Collaborate with Global CAPA teams, acting as the first point-of-contact for giving guidance and news sharing from the global CAPA team.
- Take charge of CAPAs, including planning, processing, reviewing content and executing CAPA training.
- Be an active member of the Central CAPA Review Board, attend meetings, review and escalate overdue CAPAs, and moderate the board in the absence of the Global CAPA Officer.
- Support in processing potential CAPA checks and align on necessary actions to ensure compliance across WSA entities.
- Plan, perform, and document internal audits for WSA entities, focusing on the APAC region (moderate travel required).
- Participate in and support internal and external audits, ensuring thorough preparation and execution.

**What you bring**:

- Experience_
- University or Master’s Degree in Engineering or a related field.
- Minimum of 3 years of experience in Quality Management Systems in the Medical Device or Medical Technology Industry is required.
- 1-3 years of auditing experience including auditor qualification, preferably within the Medical Device or Medical Technological Industry.
- Strong understanding of CAPA and Root Cause techniques, Statistical Techniques, GMP, GDP, ISO 13485, and QSR.
- Personal competencies_
- Excellent internal and external communication skills are essential. Detail-oriented and able to work effectively in a team environment.
- Highly motivated, passionate about problem-solving, and detail-oriented with excellent interpersonal skills.

***:
**Who we are**:
At WS Audiology, we provide innovative hearing aids and hearing health services.

Together with our 12,000 colleagues in 130 countries, we invite you to help unlock human potential by bringing back hearing for millions of people around the world.

With us, you will become part of a truly global company where we care for one another, welcome diversity and celebrate our successes.

Sounds wonderful? We can't wait to hear from you.
- WS Audiology is an equal-opportunity employer and committed to creating an inclusive employee experience for all. Regardless of race, color, religion, national origin, age, sex, gender, gender identity, gender expression, sexual orientation, marital status, medical condition, ancestry, disability, military or veteran status we firmly believe that our work is at its best when everyone feels free to be their most authentic self._

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