Supplier Quality Engineer

The Supplier Quality Engineer interacts with our suppliers on matters related to product quality. This position maintains and improves our Supplier Management System which includes supplier qualifications, supplier audits, supplier corrective action process and scorecards. Supports complex root cause failure investigations and troubleshooting of customer complaints and product non-conformances within manufacturing. Acts as the champion of Quality System compliance.

ESSENTIAL FUNCTIONS:

• Evaluates suppliers for technical capability and quality system performance. Leads and positively influences product improvements of supplied products through effective use of our quality system.   
• Leads the site effort in managing the nonconforming material functions through effective identification, segregation, technical root cause failure analysis and disposition of material resulting in sound corrective action at the supplier site to prevent reoccurrence. (SCAR System Administration)
• Actively reviews existing Raw Material Specifications, supplier capability, and the corresponding Receiving Inspection Instructions for accuracy and applicability.
• Supports (including leading as needed) root cause failure investigation activities.
• Writes/edits/approves investigation reports.
• Participates in Complaint Committee meetings and present investigation findings to peers and management.  
• Represents the Quality Control department in evaluating failures, performing technical root cause analysis and developing and executing corrective and improvement actions.
• Performs statistical analysis of data from experiments and manufacturing process trend monitoring.
• Attends and actively participates in Management Review Board and presents findings and recommendations.

EDUCATION & EXPERIENCE:

• B.S. in Engineering/Technical Discipline or equivalent combination of certification and work experience is preferred.
• 3-5 years’ experience in Quality and Manufacturing Systems in Medical Device and high-volume manufacturing environments, with a minimum 3 years’ experience in Supplier Quality Engineering.
• ASQ Quality Engineer Certification (CQE) preferred

KNOWLEDGE & SKILLS

• Supplier Quality skills and experience including auditing, performance management and SCAR management.
• Problem Solving Methodologies/Process Capability / ISO 13485 / Design of Experiments / Sampling Plans.
• Experiences in providing leadership to technical teams and the use of problem-solving methodologies such as DMAIC, Ishikawa, Kepner / Tregoe etc.
• Strong technical aptitude and experience is a required, level of technical writing skills and abilities.
• Excellent communication skills are required.
• Medical Device Manufacturing experience required. 
• Ability to communicate effectively with all levels of employees throughout the organization.  Able to develop and maintain strong working relationships with internal and external customers.
• Experience interacting with Regulatory Bodies (FDA, ISO) is required.
• Proficient in Microsoft Office, statistical software programs, operating systems, voice and email, etc.
• Ability to lead and facilitate a group of technical experts (including suppliers) in root cause investigations.
• Knowledge of quality systems and regulations for medical device industry.
• Must have a strong understanding of manufacturing and quality systems principles is required.
• Advance skills in statistical techniques and methods required.