1) Job description:
· Overseeing the entire spectrum of quality assurance for the Singapore and overseas offices, ensuring consistency and alignment in quality standards and practices and maintaining quality management system across these locations.
· Leading and supervising all aspects of quality assurance, from incoming, in-process, semi-finished, to outgoing product quality. Driving improvements in the efficiency and effectiveness of the incoming quality assurance process.
· Managing product inspection and ensuring compliance with customer specifications and requirements.
· Collaborating with subcontractors and suppliers to ensure the quality of parts and products, while spearheading quality improvement initiatives.
· Acting as the owner of the non-conforming system, analyzing non-conforming quality incidents and internal errors, and providing recommendations to meet both internal and customer requirements and expectations.
· Coordinating with HQ for any system upgrades or changes related to quality assurance.
· Supporting the customer quality engineering team in investigating customer product complaints.
· Reporting quality KPIs to senior management.
· Providing leadership and expert advice on quality-related matters.
· Developing quality strategies to enhance the company's quality culture, processes, products, and systems, while also planning and leading manufacturing process audits.
· Leading third-party audits - customer audits.
· Supporting and coordinating with HQ for local and international product registration.
2) Qualifications and attributes:
· A minimum of a Degree in a relevant subject area, with 3 years or more of experience in medical device quality assurance, is highly advantageous.
· ISO 13485:2016 certification as an internal auditor, or equivalent experience, is highly advantageous.
· Proficiency and comfortable in using quality control tools (E.g.: Charts/ Check Sheets, etc).
· Strong PC skills, particularly with Microsoft Office Suite (E.g.: Word, Excel, Outlook).
· Excellent communication and customer service skills, with the ability to effectively communicate in both Mandarin and English.
· A growth mindset, both in your professional work and personal life.
· The physical ability to lift over 30KG when necessary.