Head of Quality Assurance (QA)
PlanetFull Time
Junior (1 to 2 years)
Candidates must possess a Bachelor's degree in science or engineering fields or equivalent experience, with a minimum of 15 years of professional quality experience in the Life Sciences, Medical Device, Pharmaceutical, or IVD industry. Required qualifications include a strong customer focus, the ability to implement robust quality systems like ISO 9001, ISO 13485, and MDSAP, proven team-building skills, a clear understanding of operational execution for quality assurance, and the flexibility to manage multiple complex projects simultaneously. Preferred experience includes IVD/IVDR, 510K, and GXP requirements.
The Director of Quality will lead the Singapore site quality teams, developing quality system and assurance plans to support GSD and LSG businesses, ensuring alignment with internal and external quality regulations. Responsibilities include leading quality systems, strategic planning, monitoring regulations, integrating and improving the QMS, and enhancing product quality. The role involves developing a quality vision, leading and developing the site quality organization, using continuous improvement skills, establishing site-wide QA priorities, implementing and ensuring adherence to quality systems aligned with 21 CFR 820, ISO 9001, ISO 13485, MDSAP, CE-IVDD, and CE-IVDR, and collaborating with corporate, group, and divisional quality partners. Additionally, the Director will foster connections within LSG and regions, develop the continual improvement of Quality Management Systems, support New Product Introductions, collaborate with the Regulatory organization, and serve as the Management Representative for Singapore to the US FDA and Notified Bodies.
Provides life sciences products and services
Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.