Senior Engineer, Supplier Quality

QUALIFICATIONS:

 

 

Required:

• Bachelor's degree or higher in Mechanical Engineering, Biomedical Engineering, or related field from an accredited university.
• A minimum of 6 years of relevant experience; OR master’s degree in related field plus 4 years’ experience

 

Preferred:

• ASQ Certified Quality Engineer (CQE), ASQ Certified Quality Auditor (CQA)

 

Skills & Competencies:

• Proficiency in MSA principles, Geometric Dimensioning and Tolerancing (GD&T), methods of risk-management, Minitab statistical software, tolerance stack analysis, process and manufacturing controls, software quality concepts, CAPA, non-conformances, post-market surveillance, Microsoft Office tools.
• Strong analytical and creative problem-solving skills.
• Excellent verbal communication and technical writing skills.
• Possesses working knowledge in FDA, CE Regulatory, and New Product Design processes.
• Demonstrates technical coaching and leadership of peers.

 

Physical Requirements:

• Must be able to remain in a stationary position for extended periods of time
• Ability to constantly operate a computer and other office equipment, such as printer, telephone, etc.
• Ability to move about inside the office to access file cabinets, office machinery, etc

 

 

 

RESPONSIBILITIES:

• Manage supplier quality documents and conduct periodic reviews.
• Conduct periodic onsite and remote audits of critical suppliers.
• Manage supplier corrective action activities and completion of reports.
• Communicate with Supplier Quality Leaders on quality performance and areas for improvement.
• Support the data collection and analysis for Supplier Performance Scorecards.
• Approve new suppliers.
• Facilitate qualification of components including writing validation protocols and reports for component qualifications as needed.
• Ensure accurate and controlled supplier quality documents are generated.
• Drive improvements utilizing Lean methodologies using supplier scorecards and rankings.
• Coordinate inspection fixture procurement and integration of fixtures at the supplier.
• Troubleshoot material non-conformances with suppliers.
• Contribute to supplier continuous improvement activities.
• Develop and support strong collaborative relationships with external design/development, manufacturing partners and suppliers.