Quality Partner - Operations Quality Product Partnering RDI

Position: Operations Quality Product Partnering

We are looking for a highly motivated and dedicated Quality Partner with experience in product care and improvement of medical devices and IVDs.

Responsibilities

• Ensure compliance with Roche requirements and laws, regulations, and standards (FDA, EU IVDR, ISO 13485, etc.) in design transfer to production, manufacturing, and related changes.
• Review and approve changes (Change Control) within the manufacturing process and product care.
• Review and approve project, product, and process documentation and mandatory manufacturing documentation (work instructions, templates, checklists).
• Review and approve deviations (Nonconformities).
• Ensure that quality‑related product release activities in your area, such as product review and release, are completed in a compliant and timely manner.
• Take responsibility for quality aspects in design or technical product transfer proj...