Supplier QA Engineer – P3

About the role

The Supplier QA Engineer drives improvement and corrective action in the quality of components sourced from external suppliers for medical devices. The role provides technical support for supplier selection, develops acceptance criteria, and monitors supplier performance to ensure compliance with regulatory standards.

Key responsibilities

• Assess potential new suppliers for technical, quality, and manufacturing capabilities.
• Generate and maintain incoming inspection procedures and train inspectors.
• Develop or source inspection tools and equipment.
• Create test protocols, monitor testing, issue qualification reports, and approve components.
• Analyze incoming material defects, drive corrective actions, and communicate issues to suppliers.
• Investigate field failures related to supplier materials and develop corrective action plans.
• Provide input to Design Engineering on new component technology and assist in component selection.

Required profile

• Licentiate degree in Material Science, Chemical, Mechanical (emphasis on polymers) or related field.
• At least 4 years of experience in supplier quality or equivalent education/experience.
• English proficiency 80‑89%.
• US visa required.
• Willingness to travel to supplier sites as needed.

Required skills

• Knowledge of QSR and ISO standard requirements (ISO 13485, ISO 9001) for material/purchasing controls, validation, and CAPA.
• Experience with plastic components, extrusion, molding, and supplier quality management.
• ASQ certification and project management skills (desired).
• Ability to develop inspection procedures, tools, and test protocols.