Quality Assurance Specialist I

Job Description

Job Summary:

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

Duties and Responsibilities:

• 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.

Education & Experience:

• Two or more years of experience in Quality or a related function.
• Bachelor’s / Master’s degree in Life Science, Data Science, or a related subject or equivalent experience.
• Professional experience in a similar role within the medical device sector.

Knowledge, Skills, and Abilities:

• 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.
• Strong analytical skills with a focus on essential facts.
• Excellent communication skills.
• Cultural awareness and experience interacting with global internal and external partners and suppliers.
• Leadership mindset with the ability to lead others within an agile organization.
• Willingness and flexibility to collaborate cross-continentally in a global team across different time zones (may require early working hours to ensure close collaboration with colleagues in the European Union).
• Decisive and able to initiate and complete daily activities and proactively find solutions independently with limited guidance.