Job Description

Our client, a digital clinic headquartered in the US develops healthcare software solutions to allow remote digital care. They are a leading digital clinic for back, joint and muscle pain.

They are seeking an experienced and dynamic individual to join their expanding team as a Supplier Quality Manager. This role provides world-class quality management, to help create the systems that measure and improve product quality and cost, in compliance with ISO and FDA standards. The Supplier Quality Manager will need to assess, establish, implement, and track the Quality and Compliance of hardware products, both in design and at suppliers, manufacturers, and 3PL partners.

This is a remote role, reporting to HQ and the US.

:

- Conduct detailed evaluations of current and potential contract manufacturers and suppliers to ensure that the company has quality-oriented scalable partners whilst growing to an IPO-ready and FDA-ready company

- Aid the selection and negotiation of the correct partners, while championing quality in components, manufacturing, performance, and returns

- Provide expertise on NPI manufacturing and quality controls as well as Quality planning and assessments

Requirements:

- Bachelor\'s Degree or Master\'s degree in Biomedical Science or relevant disciplines

- 5-8 years of clinical and manufacturing quality assurance experience in biotechnology, pharmaceutical or medical devices industry

- Through understanding of ICH GCP, GMP and other relevant guidelines

- Strong knowledge of FDA, EMA and other applicable local regulations

- Hands on experience of successful application of six sigma and lean manufacturing tools

- Excellent analytical and interpersonal skills with strong problem-solving capabilities

- Project Management: Ability to coordinate several projects simultaneously and work to a strict schedule.

- Proven analytical and organizational ability

- Tenacious although professional when working with supplier challenges

The Talent Shark