The role
The Supplier Quality Engineer assures products conform to quality standards and establishes compliance with the quality system. Responsible for maintaining a strong collaborative partnership with cross-functional team members and suppliers that facilitates organizational success by protecting patient/user safety and meeting business needs.
Responsibilities
- Leads supplier audits and supplier onboarding
- Supports manufacturing by leading the resolution of manufacturing and supplier issues
- Conducts and leads non-conformance risk assessments
- Works directly with suppliers to facilitate new product development and sustaining projects
- Identifies and implements improvements to quality system procedures
- Reviews and approves design and manufacturing changes
- Ensures product conformity to internal and external quality requirements
- Leads supplier CAPA investigations and implements corrective/preventive actions
- Performs other duties as assigned
- Bachelor’s degree in engineering discipline
- Minimum 5 years of experience working in the medical device industry
- Strong mechanical aptitude and problem-solving skills
- Strong understanding of ISO 13485 and FDA 21 CFR Part 820 requirements
- ISO 13485:2016 Lead Auditor Certification preferred
- Excellent communication and documentation skills
- Ability to travel and audit domestic and international suppliers