Senior Supplier Quality Engineer

• Management of supplier transfers within the Global Supplier Quality Supplier Change Implementation Team.
• Provide Quality Assurance Engineering representation to select business teams facilitating front-end design, design transfer to manufacturing, and process improvements.
• Coordinate feedback of quality indicators and statistics to business team for use in business decisions.
• Perform, direct, or consult in supplier validations.
• QA approvals for Engineering Change Notices, test methods, and test equipment.

• Bachelor’s Degree in Engineering, Science or technical field with 4+ years of work experience in a regulated industry OR Advanced Degree in Engineering, Science or technical field with 2+ years of work experience in a regulated industry OR PhD with 0 years relevant experience.
• Strong knowledge of Supplier Controls, including creation and maintenance of supplier files in the Approved Supplier List (ASL).
• Experience with Windchill and Agile PLM systems.
• Working knowledge of FDA regulations and ISO standards for implantable and non-implantable medical devices.
• ASQ certification preferred, such as CQE, CQA, and/or CSQP.
• First Time Quality Coach (FTQ) Six Sigma, DFSS, or Lean Green Belt/Black Belt certified.
• Knowledge of PPAP, part/product validation, and qualification processes.
• Strong technical knowledge of metrology, measurement techniques, GD&T, measurement uncertainty, Gauge R&R, and statistical analysis using tools such as Minitab.
• Demonstrated ability to influence and negotiate with suppliers and lead successful change initiatives.
• Strong project leadership skills, including balancing risk and benefit, influencing cross-functional teams, and driving accountability for outcomes.
• Excellent communication, organizational, presentation, judgment, and problem-solving skills, with the ability to operate strategically and tactically (especially root cause analysis).

Demonstrates expertise in Supplier Quality Management, including Supplier Controls and validation processes, while effectively leading cross-functional teams and influencing supplier relationships. Proficient in regulatory compliance with FDA regulations and ISO standards, alongside strong analytical skills in metrology and statistical analysis.

• Supplier Controls Management
• FDA Regulations Knowledge
• ISO Standards Compliance
• Six Sigma Certification
• Project Leadership Skills

• Supplier Validation
• Metrology
• Statistical Analysis
• GD&T
• Measurement Techniques
• Part/Product Validation
• Quality Assurance Engineering
• Change Management
• Root Cause Analysis
• Process Improvement

• Communication Skills
• Organizational Skills
• Problem-Solving Skills
• Negotiation Skills
• Presentation Skills

• ASQ Certification
• CQE
• CQA
• CSQP
• Six Sigma Green Belt
• Six Sigma Black Belt

• Regulated Industry
• Medical Devices
• Approved Supplier List
• First Time Quality Coach
• PPAP

• Windchill
• Agile PLM
• Minitab