Quality Assurance Engineer I – 12‑Month Temporary Role

About the role

The Quality Assurance Engineer I (Complaints) supports complaint handling and post‑market surveillance for a defined product portfolio. Working in a hybrid environment, the engineer monitors product quality performance, analyses complaint trends, and ensures compliance with corporate and regulatory standards.

Key responsibilities

• Lead monthly complaint signal evaluations (SEF) and coordinate with reviewers, approvers, and data‑analytics partners.
• Approve complaint investigations in line with quality and corporate expectations.
• Maintain the complaint backlog within defined performance targets.
• Support complaints review board activities by delivering timely analyses and documentation.
• Execute and support NCEPs/CAPAs and other complaint‑related compliance activities.
• Contribute to product transfer projects, new product introductions, and lifecycle initiatives.
• Act as subject‑matter expert for well‑established products and participate in complaint reduction initiatives.
• Collaborate with cross‑functional partners to resolve quality and complaint‑related issues.

Required profile

• Bachelor’s degree in Engineering or a related field.
• English proficiency at B2–B2+ level (70‑89%).
• Experience or familiarity with medical‑device, pharmaceutical, or other regulated industries (preferred).
• Ability to perform data analysis and produce technical documentation.

Required skills

• Data analysis
• Technical documentation
• Statistical analysis
• Six Sigma methodology
• APQP (Advanced Product Quality Planning)
• Quality‑technique training or certification (e.g., ASQ)