POSITION SUMMARY:

This position will be responsible for the development and implementation of supplier-related quality system requirements including compliance with international and domestic regulations in support of new product development, manufacturing, and quality management system activities with a focus on continuous improvement.

ESSENTIAL FUNCTIONS OF THE POSITION:

• Develop and maintain supplier-related procedures and requirements in compliance to FDA regulations, MDD, CMDR, and ISO requirements including evaluations, audits, and metrics
• Direct and support supplier-related activities, including:
  • QMS qualification and monitoring including supplier audits and assessments
  • Component (and sub-assembly) qualification elements such as defining requirements and assessing First Articles, Measurement Systems, equipment and process qualifications, Control Plans, etc.
  • Correction activities including managing NCRs and SCARs.
  • Supplier change requests and improvement
• Work closely with Quality Management, Product Development, and other departments in developing and executing company strategies
• Able to support both New Product Development activities at suppliers as well as sustaining activities for existing components and subassemblies.
• Able to work cross-functionally, overcome challenges, and facilitate cooperation with suppliers to meet regulatory requirements
• Assist with FDA and ISO audits. Perform internal and supplier audits as necessary
• Strong working knowledge of domestic and international standards and controls relevant to the duties and expectations of this position
• Operates with appreciable latitude for, and assumes ownership of, actions and/or decisions on day-to-day activities.
• Determines appropriate response to novel or controversial problems that may impact the business significantly
• Uses knowledge of best practices and technical proficiency in supplier quality engineering to mentor junior SQE’s. Other duties as necessary and assigned

ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION:

• Regular and predictable work performance
• Ability to work under fast-paced conditions
• Ability to make decisions and use good judgment
• Ability to prioritize various duties and multitask as required
• Ability to successfully work with others
• Additional duties as assigned

BASIC QUALIFICATIONS:

• Bachelor’s degree required or demonstrated equivalent combination of education, training and experience.
• 4+ years of experience
• FDA and ISO 13485 knowledge and audit experience
• Willingness to travel
• Experience with inspection/testing and data analysis
• Strong computer/data entry, report writing, and communication skills
• Details-oriented with strong problem solving/trouble shooting experience
• Must be able to read technical specifications, blueprints, and drawings
• Engineering/design background
• Ability to travel 25%

PREFERRED QUALIFICATIONS:

• MDD, CMDR and JPAL knowledge
• ASQ Certified Quality Engineer
• ASQ Certified Quality Auditor or ISO13485 Lead Auditor certification
• Statistical use experience
• Experience with Metal Injection Molding (MIM) suppliers

OTHER REQUIREMENTS:

• Ability to regularly walk, sit, or stand as needed
• Ability to occasionally bend and push/pull as needed
• Ability to regularly lift up to 25 pounds, occasionally lift over 25 pounds
• Ability to pass pre-employment drug screen and background check

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