Supplier Quality Engineer

About the role

Trelleborg Medical Solutions seeks a Supplier Quality Engineer to support manufacturing processes within a regulated medical device environment. The role focuses on managing supplier quality, leading corrective actions, and driving continuous improvement across the supply chain.

Key responsibilities

• Maintain the Approved Supplier List (ASL) and assess new suppliers for technical, quality, and manufacturing capabilities.
• Support engineering and inspection teams in analyzing incoming material defects and participate in Material Review Board (MRB) activities.
• Coordinate supplier audits and develop the annual audit plan, ensuring compliance with ISO 13485, ISO 9001, and 21CFR Part 820.
• Issue Supplier Corrective Action Requests (SCARs), track non‑conformances, and lead risk assessments and mitigation plans.
• Collaborate with suppliers to create control plans, manage change control, and lead cost‑reduction projects related to quality.

Required profile

• Bachelor’s degree in Quality Engineering or a related field.
• Minimum 3 years of experience in a regulated manufacturing environment.
• ASQ Certified Supplier Quality Engineer/Auditor preferred.

Required skills

• Knowledge of ISO 13485, ISO 9001, and FDA 21CFR Part 820 (including 210/211).
• Experience with GMP, ICH Q7, CAPA, SCAR processes, and risk assessment methodologies.
• Ability to plan and conduct supplier site audits and manage audit findings to closure.