As a Supplier Quality Engineer I, you will play a key role in maintaining the integrity of medical device manufacturing by overseeing quality across external production partners. You'll work closely with contract manufacturers and original equipment manufacturers to ensure components and materials meet rigorous regulatory and performance standards.
What You'll Do
- Monitor and manage supplier quality to ensure delivery of compliant parts, materials, and services
- Lead change control processes, including review and approval, to maintain compliance and traceability
- Oversee product and process changes in active production, addressing design, material, or process deviations
- Develop and assess test plans and reports for validations, supplier certifications, and special processes using PPAP when applicable
- Collaborate with sub-tier suppliers to strengthen quality systems and ensure long-term stability
- Drive resolution of findings from testing, qualification, and audit activities
- Manage nonconforming product investigations from initiation through final disposition
- Support root cause analysis for customer complaints, overseeing supplier-led investigations
- Participate in internal and external audits, including those conducted by regulatory bodies
- Develop supplier performance metrics using statistical methods to identify supply chain improvements
- Lead or support sustaining initiatives such as process transfers, label updates, and supplier qualifications
- Conduct assessments of potential and existing suppliers to verify compliance with quality standards and company requirements
Requirements
- Bachelor’s degree in Engineering, Science, or a technical discipline
- Experience in quality, manufacturing, or engineering roles within regulated industries preferred
- Familiarity with medical device regulations and quality management systems
- Knowledge of process validation, nonconformance controls, and failure investigation methods
- Proficiency with statistical tools including DOE, MSA, SPC, and process capability analysis
- Strong written and verbal communication skills
- Experience with manufacturing processes such as molding, machining, and PCB assembly is advantageous
- Working knowledge of Agile, Microsoft Office, and PPAP procedures
Benefits
- Opportunity to contribute to life-changing medical technologies
- Commitment to ethical practices and patient safety
- Support for professional growth and innovation
- Focus on equitable healthcare access and global impact
- Work environment centered on integrity, collaboration, and accountability
