What are the responsibilities and job description for the Manager, Supplier Quality position at Enable Injections, Inc.?
Title: Manager, Supplier Quality
Description
QUALIFICATIONS
Required
Description
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
- 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
- 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
- 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
- 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.
