A rapidly expanding medical devices manufacturer is growing their Quality team in APAC and they are looking for a meticulous and driven Quality Specialist to join their team. You will be reporting to the Senior Market Quality Manager, supporting him in day-to-day responsibilities in commercial quality area.
What the role entails:
- Maintenance of quality management systems and ensure compliance to ISO 13485 and other relevant international regulations and standards in Singapore (with exposure to SEA regions)
- Liaise closely with cross-functional teams (e.g. RA, marketing, planning, etc) to ensure clear communication and achievement of business objectives.
- Establishing and executing quality and compliance activities such as internal and supplier audits, CAPA board meetings, complaints handling, assisting in preparation of technical files, change management, etc.
- Establishing and implementing of global quality policies on a regional and global level and be responsible for training of internal stakeholders to ensure quality objectives are being understood
- Gathering and trend quality data for quality management reviews.
What we are looking for:
- A degree in biomedical engineering discipline or equivalent
- Minimum 5 years of quality experience in medical device industry is preferred
- Strong knowledge in ISO 13485, GDPMDS/GDPMD is advantageous
- Strong communication and presentation skills are necessary as you will be working very closely with various internal and external stakeholders
Please send your resume in WORD format by clicking the apply button below or contact Kareen Wong on +65 6701 1518 for a confidential discussion. Please note that only short-listed candidates will be contacted. CEI Reg. Number R1878552 (Wong Yin Ling, Kareen).