QUALIFICATIONS

Required:

• Bachelor's degree or higher in Engineering, or Science related field from an accredited university
• A minimum of 10 years of Quality Engineering Experience with a minimum of 5 years focused on Supplier Quality Engineering.
• Experience working with suppliers in a leadership role

Preferred:

• Certified Quality Engineer
• Certified Quality Auditor or Certified Lead Auditor
• Experience with process validation activities
• Experience with component development activities for medical devices
• Experience in an FDA regulated environment

Skills & Competencies:

• Communicate effectively throughout our company and directly with suppliers
• Ability to perform root cause analysis and resolve problems
• Strong analytical and creative problem-solving skills
• Excellent verbal communication and technical writing skills
• Demonstrates quality coaching and leadership
• Ability to work with suppliers to resolve issues and advance Enable objectives

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.
• Wear clean room gowns, hair nets, gloves, safety glasses, and shoe covers for extended periods of time
• Ability to operate lab instrumentation and equipment
• 10 - 15% travel by car or airplane

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.
• Manage the supplier quality budget.
• 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.
• Manage 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.
• May manage the work efforts of individual contributors which includes hiring, performance management, and pay reviews.