The Supplier Quality Engineer ensures that product designs may be verified through supplier inspection methods and equipment to meet specifications.

Essential Job Functions:

·         Leads quality-related communications with suppliers.  Coordinates with Purchasing and Engineering in these communications.

·         Qualifies and disqualifies suppliers for Company according to quality system requirements. 

·         Maintains supplier files and the Approved Supplier List.  This includes the qualification and disqualification of suppliers.

·         Establishes and leads the supplier audit program.

·         Leads the review of supplier quality performance. 

·         Works with suppliers to improve performance, as required.

·         Manages the SCAR process.

·         Coordinates and secures supplier responses to nonconformance reports, SCARs, and audit findings

·         Establishes and manages supplier quality metrics. 

·         Works with Purchasing to communicate metrics with suppliers and to secure any required responses.

·         As required, evaluates proposed product design changes for measurement requirements, regulatory compliance, and impact on product quality.

·         Leads the Material Review Board evaluation and disposition of non-conforming products, components, and materials.  Ensures required supplier correction and corrective actions are completed.

·         Works with engineers and Inspection Services to establish supplier and receiving inspection requirements.

·         Assists suppliers in defining and executing complex mechanical measurement setups using appropriate measurement equipment

·         Designs and obtains supplier measurement gaging, as required.  Ensures proper supplier application of gaging.

·         Works with Inspection Services and suppliers to ensure conformance to specifications of material provided by suppliers.

·         Assists supplies in applying statistical methods such as SPC and statistical sampling methods.

·         Trains suppliers related to product quality, regulatory issues, and processes.

Knowledge, Skills and Abilities:

·         Working knowledge of:

·         Current FDA Quality System Regulation

·         ISO 13485:2003

·         Ability to use standard mechanical measurement equipment, including but not limited to:

·         Calipers

·         Micrometers

·         Pin gages

·         Go/no go gages

·         Optical comparators

·         Height gages

·         Experience with measurement equipment control methods, such as calibration, maintenance, and Gage R&R.

·         Ability to read and interpret engineering drawings and specifications, including metric or English specifications and GDT specifications

·         Ability to define inspection/measurement requirements for engineering drawings

·         Basic knowledge of statistics and compilation of trend charts used in supplier performance management

·         High degree of attention to detail

·         Excellent communication skills, both oral and written

Work Experience Qualifications:

·         Minimum of 5 years Supplier Quality Engineer or Quality Engineer experience with a medical device manufacturer.

·         Minimum of 5 years experience in supporting metal machining operations as a Quality Engineer or measurement specialist.

·         Work experience in an orthopedic and/or spinal implant manufacturer is highly desirable.

Education and/or Certifications:

·         Baccalaureate degree in technical area. 

·         Mechanical Engineering degree is preferred

·         ASQ Quality Engineer certification is highly desirable

·         ASQ Quality Auditor certification is highly desirable