Cardinal Health Senior Principal Quality Engineer (Post Market) in Massachusetts, Massachusetts

Senior Principal Quality Engineer (Post Market)

What is expected of you at this level:

  • Lead and support key post market quality efforts within the Cardinal Health Patient Care Businesses.
  • Collaborate with all pre and post-production functions (R&D, manufacturing, post market vigilance, CAPA, change development, Supplier Quality, etc.) to ensure the proper application, use and updates of risk management files following product launch
  • Monitor Post Market Complaint trends within the Cardinal Health Patient Care to assess opportunities for improvement
  • Provide assessment of post-market risk related to field issues and provide response to regulatory body inquiries as necessary
  • Drive continuous improvement through CAPA by leading, and collaborating with cross functional teams including Quality, R&D, Marketing, and Medical/Clinical Affairs
  • Create internal communications to support procedural and process requirements and reports for health agencies as required
  • Understand therapy and clinical performance, products, and product use environments to appropriately and strategically apply technical knowledge, tools and methodologies to drive product quality

Accountabilities:

  • Follow and maintain quality system policies and procedures to ensure that products and processes meet applicable standards and specifications
  • Coordinate business meetings to communicate and align on product issues and ensure appropriate decision making is made to initiate actions or support documentation for no action required
  • Create and maintain documentation per SOPs and FDA guidelines
  • Internal reporting and project tracking needs for business management
  • Analysis and evaluation of product field returns and performance trends
  • Lead Corrective Action and Preventive Actions (CAPA) activities
  • Collaborate/interface with Clinical, Quality, Marketing, and Product Development on field corrective action plans. Interface directly with customers on issues, as needed

Qualifications :

  • B.S. in Engineering or associated scientific discipline, Required
  • Working knowledge of Product Risk Standards (ISO14971, IEC 60601, pFMEA, dFMEA, etc.) and Quality Medical Device Regulations (FDA 21CFR 820, 806, 803, 804, ISO13485, and MDD), required
  • 8 years Medical Devices experience in Quality or R&D Engineering position, preferred
  • Design for Reliability (DfR) OR Design for Reliability and Manufacturability (DRM), strongly preferred
  • DFSS or DMAIC Black Belt Certified or Certified Quality Engineer (CQE) or Certified Reliability Engineer (CRE) preferred
  • Ability to demonstrate problem solving skills pertaining to working knowledge of Corrective Action and Preventive Actions (CAPA)
  • Working knowledge of Design, Quality, Development Engineering, Clinical Affairs, and Manufacturing principals

Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.