CA: Supplier Quality Engineer x2 (234193)

Life Sciences & Technology | Validation


12 Months

Job Description:

Our client is looking for a Sr. Supplier Quality Engineer to support the maintenance, management, and improvement of suppliers. This candidate will be tasked with owning the product qualification plan which includes identifying the component, features of the component, risk level, quality requirements, validation requirements, and then execution. Products are blended across Molding, Machine, Extrusion and Catheter components. Key Responsibilities include:

  • Support component specification development, identification of critical features, development of inspection methods and plans, test method validation, and component capability assessments
  • Lead risk management activities, including the development and implementation of FMEAs, process control plans, and quality agreements at suppliers.
  • Support suppliers in the development, approval and execution of process validation protocols and reports for critical processes
  • Utilize statistical techniques and six sigma tools to analyze processes and drive continuous improvement activities.
  • Collect and analyze Quality metrics relating to Supplier Quality

The ideal candidate will have 5+ years of Supplier Quality Engineering, possess a background in NPD or Manufacturing engineering for medical devices and a complex understanding of technical documents including diagrams, parts specifications, and blueprints.


Supplier Quality, Quality Engineering, TMV, Process Validation, Device Development/Engineering, ISO 13485


Mechanical Engineering or related degree

CA: Supplier Quality Engineer x2 (234193)


About Black Diamond Networks
Black Diamond Networks delivers talent uplifted. We deploy highly skilled consultants to support quality, compliance, and innovation in regulated industries and beyond. Black Diamond’s delivery model is wired for speed and precision, due to a cultivated community of experts in life sciences, engineering, and technology. Raise your expectations for dynamic solutions.

Black Diamond Networks is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

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