Quality Assurance Specialist

The primary responsibility is managing the ETE IVDR/MDR product verification process for products within Roche's distributed products portfolio, including determining requirements and controls for those products and completing objective evidence of supplier evaluation and approval.

Duties:

• Manage SCARs (Supplier Corrective Action Requests) and successfully complete them, as well as address other supplier gaps in a timely manner by tracking robust corrective action plans.
• Complete onboarding activities for suppliers.
• Monitor supplier performance.
• Plan and follow up on supplier audits and ensure resulting supplier actions are sufficient to resolve quality issues and are completed in a timely fashion.
• Identify and escalate issues as they arise and provide adequate solutions.

Qualifications:

• Bachelor’s / Master’s degree in Life Science, Data Science, or a related subject or equivalent experience.
• 2+ years of experience in Quality or a related function.
• Professional experience in a similar role within the medical device sector.
• Knowledge of deviation and resolution management.
• Expertise in quality systems, standards and regulations, specifically production and/or supplier development processes and standards such as ISO 13485 and ISO 27001.