Supplier Quality Assurance Manager

Summary: An experienced Quality professional who works well in a cross-functional team environment. The individual will lead our efforts to attain and maintain medical device Supplier Quality Assurance compliance, as well as improving our Supplier Quality Engineering efforts. Core values must include commitment to customer excellence with demonstrated ethics and integrity.

Duties and Responsibilities:

  • Develops, implements and maintains Supplier Quality procedures to assure compliance with medical device requirements and standards.
  • Recommends and implements improvements to the Supplier Quality Assurance and Engineering Program.
  • Works closely with cross-functional teams to ensure company maintains high-quality suppliers and to provide appropriate feedback to suppliers.
  • Provides leadership for Supplier Quality Engineers in working with Purchasing, Operations, Manufacturing Engineering and Suppliers to resolve supplier quality issues
  • Leads Supplier Quality efforts with new product introductions, cost reduction projects, and part sourcing activities.
  • Develops and maintains supplier performance metrics, develops trend data of supplier related processes.Communicates data to senior management and suppliers, as appropriate.
  • Leads investigations and assures follow up and corrective action closure to reduce and eliminate supplier related defects.
  • Leads teams/projects related to supplier complaint investigation, corrective actions and quality system excellence.
  • Develops and maintains Supplier Audit schedule, and provides training/oversight of the supplier audit process.
  • Provides leadership, mentoring and career development to Supplier Quality Engineers

Job Requirements :

  • Requires a BS in Engineering, Mechanical or Manufacturing preferred, with a minimum of 5-8 years related experience and/or training; or equivalent combination of education and experience.
  • Experience in the application of Supplier Quality Assurance/Engineering in the Medical device industry, including Supplier qualification and audits.

Knowledge, Skills & Abilities:

  • Strong knowledge of Medical Device Regulations and Standards (FDA, ISO 13485, ISO 14971, MDD, IVDD).
  • Ability to identify, analyze and solve problems with minimal direction and make decisions with confidence.
  • Ability to read drawings and use inspection measuring equipment
  • Superior communication skills, both oral and written and ability to develop cross functional partnerships.
  • Commitment to continuous improvement principles.

PerkinElmer is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability status, age, or veteran status or any other characteristics protected by applicable law. PerkinElmer is committed to a culturally diverse workforce.

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