This role focuses on ensuring the consistent quality of medical device components produced by external manufacturing partners. The Supplier Quality Engineer I plays a key part in maintaining compliance with regulatory and internal standards by overseeing supplier performance, managing change control processes, and resolving quality issues.
Key Responsibilities
- Monitor and coordinate change control activities, including review and approval, to ensure compliance with regulatory and product requirements
- Oversee modifications to production processes and products to resolve design, material, or process-related issues
- Lead initiatives to improve and streamline quality processes across the supply chain
- Develop and evaluate test plans and reports for supplier certifications, material changes, and special processes, applying PPAP as needed
- Engage with sub-tier suppliers to promote stable, reliable quality outcomes
- Drive resolution of issues identified during testing or qualification phases
- Manage nonconformance events from initial investigation through final disposition in coordination with suppliers and internal teams
- Support responses to customer complaints by overseeing supplier-led investigations
- Participate in audits of suppliers’ Quality Management Systems by corporate or regulatory bodies such as FDA, TUV, or BSI
- Develop supplier performance metrics using statistical methods to identify supply chain improvement opportunities
- Support sustaining engineering efforts including process transfers, labeling updates, sub-supplier qualification, and design verification
- Conduct assessments of existing or potential suppliers to confirm alignment with quality standards and regulatory requirements
Qualifications
A Baccalaureate degree is required. Preferred candidates hold a Bachelor’s or advanced degree in Engineering, Science, or a technical discipline, with experience in medical devices or capital equipment. Experience in supplier quality, process validation, failure analysis, and nonconforming product management is highly valued. Familiarity with Design of Experiments, Measurement System Analysis, Process Capability, and Statistical Process Control is expected. Proficiency in Microsoft Office and Agile systems is essential. Strong written and verbal communication skills in English and Spanish are an asset. The ideal candidate demonstrates the ability to collaborate effectively across internal departments and external partners.
