Are you passionate about managing Quality Systems, fostering continuous quality improvements and playing a pivotal role in educating and cultivating a compliant culture? A global leading medical devices manufacturer focusing on oncology therapy is inviting independent and highly driven Senior QA Specialist to join their growing team! You will be taking care of ASEAN and ANZ regions and have the opportunity to establish QMS in emerging markets!
What the role entails:
- Maintenance of quality management systems and ensure compliance to ISO 13485 and TGA standards and other relevant international regulations and standards.
- Liaise closely with cross-functional teams 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, preferably with a background exposure to oncology devices
- Minimum 6 years of quality experience in medical device or healthcare industry across APAC regions is preferred
- Strong knowledge in ISO 13485, TGA guidelines is highly preferred.
- Strong communication and presentation skills are necessary as you will be working very closely with various internal and external stakeholders across the regions
- Ability to travel is essential.
What is being offered?
- Conducive and flexible working culture with exposure to multiple learning opportunities
- Good remuneration and benefits package
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).