QA Manager (SG/US) - 3-Year Renewable Contract - Part-Time

About the Role

As a Global Quality Assurance Manager, you will:

Oversee the entire spectrum of quality assurance for both the USA and Singapore offices, ensuring consistency and alignment in quality standards and practices across both locations. Your responsibilities include:

• Leading and supervising all aspects of manufacturing quality assurance, from incoming, in-process, semi-finished, to outgoing product quality. You will drive improvements in the efficiency and effectiveness of the incoming quality assurance process.
• Managing product inspection and ensuring compliance with customer specifications, regulatory requirements, and applicable design and development controls under ISO 13485.
• Collaborating with subcontractors and suppliers to ensure the quality of parts and products, while spearheading quality improvement initiatives across both manufacturing and product lifecycle(including design transfer activities where applicable).
• 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 and design control / design development process improvements.
• 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.

About You

As a Global Quality Assurance Manager, we are looking for someone with the following qualifications and attributes:

• A minimum of a Diploma or Degree in a relevant subject area, with 2-3 years of experience in medical device quality assurance, is highly advantageous.
• Strong familiarity with ISO 13485 Quality Management System, particularly Design and Development controls (Clause 7.3), including design planning, design inputs and outputs, verification, validation, design transfer, and maintenance of design history documentation.
• Proficiency and comfortable in using quality control tools
• 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.

If you have a passion for quality assurance and are eager to contribute to the advancement of medical technology, we would love to hear from you! Thank you very much.