Sr Supplier Qual Engineer - Exempt

Join our dynamic team in Grand Rapids, MI, where innovation meets dedication. Our manufacturing site is pivotal in producing approximately 600 products, including cannulae and beating heart devices, all aimed at improving cardiac surgery outcomes. This role offers an exciting opportunity for professional growth and collaboration in a fast-paced environment.

Must Have

• Experience with Corrective & Preventive Actions (CAPA) using TrackWise or similar QMS software.
• Knowledge of Nonconformance, Change control, Deviations, and Good Manufacturing Practices (GMP).
• Hands-on product problem-solving experience.
• Technical engineering background in Mechanical, Industrial, Operations, or Biomedical fields.

Nice to Have

• Certification in Lean Six Sigma Yellow Belt.
• Greenbelt Certification.

Responsibilities

Responsibilities may include the following and other duties may be assigned:

• Ensure suppliers deliver quality parts, materials, and services.
• Qualify suppliers according to company standards and administer a Certified Supplier Program in receiving inspection to ensure cost-effectiveness.
• Monitor parts from acquisition through the manufacturing cycle and resolve supplier-related problems as they occur.
• Develop and prioritize an auditing schedule to ensure suppliers meet good manufacturing practices (GMP) and quality standards.
• Evaluate suppliers' internal functions to assess their overall performance and provide feedback.

Top 3 Technical Skills Required

• Supplier Quality Management & Supplier Performance Monitoring: Experience evaluating supplier performance, managing supplier quality issues, and driving improvements.
• Root Cause Analysis & Corrective/Preventive Actions (CAPA): Ability to investigate supplier-related quality issues, identify root causes, and implement effective corrective and preventive actions.
• Quality Systems & Regulatory Compliance: Knowledge of quality management systems, quality system requirements, and maintaining compliance in a regulated manufacturing environment.

Education and Experience

Requires a University Degree and a minimum of 4 years of relevant experience, or an advanced degree with a minimum of 2 years of relevant experience. This position is 100% onsite, requiring 40 hours per week.