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 leading supplier audits/assessments while training other auditors.
  • Composes and drives timely completion of 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, possibly including supplier education in these activities
  • Manage and lead Supplier change requests and improvement
• Work closely with Quality Management and other departments in developing and executing company strategies – including possible leading of small group efforts.
• Work cross-functionally, overcome technical and logistical challenges, and facilitate cooperation with suppliers to meet regulatory requirements.
• Assist with FDA and ISO audits. As necessary, perform internal and supplier audits as Audit Lead.
• 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, and driving completion of actions and/or decisions on day-to-day activities.
• Determines appropriate response to novel or controversial problems that may impact the business significantly and presents plans to resolve such problems.
• Uses knowledge of best practices, technical proficiency, and past experiences 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 with 6+ years of experience in Quality Engineering (at least 3 in Supplier Quality)
• FDA and ISO 13485 knowledge and multiple audit experiences
• Willingness to travel (~25%)f
• Demonstrated experience with inspection/testing and data analysis
• Strong computer/data entry, report writing, and communication skills. Greater use of tools above MS Office (ie. Visio, Power BI, etc) for communication and analysis.
• Statistical use experience – Assessing capability, running hypothesis tests
• Details-oriented with demonstrated problem solving/trouble shooting experience of larger magnitude.
• Must be able to read technical specifications, blueprints, and drawings. Working knowledge of GD&T
• Engineering/Manufacturing background – preferably machining, molding, and finishing processes

PREFERRED QUALIFICATIONS:

• Advanced degree
• MDD, CMDR and JPAL knowledge
• ASQ Certified Quality Engineer
• ASQ Certified Quality Auditor

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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