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Supplier Quality Engineer

New Brunswick, New Jersey | Quality Assurance / Safety

Sr. Supplier Quality Engineer

 

Our client is a highly successful, contract manufacturer in the medical device space.  The SQE’s are responsible for every aspect of the Supplier component of the QS.  Though this is an individual contributor’s role its importance to the success of the organization is paramount. 

 

The client’s success has been exceptional.  They have experienced multimillion-dollar growth and an equally impressive expansion in personnel.  As an SQE you’ll interact with suppliers on a daily basis; ensure their systems meet the needs of this employer’s QS; that Process Control is sound; that Process Change and CAPA’s are reported/resolved in a timely manner; that Supplier Quality Agreements are compliant and current, and perform onsite Supplier Audits as required by the QS. 

 

RESPONSIBILITIES:

  • Manages all the components of supplier performance per the QS, raising potential risks to Quality management and working with Suppliers to reduce/control risk
  • Leads Supplier Quality Audits updating/maintaining the Approved Supplier List, identifying/auditing potential providers and providing closure to Supplier non-conformances
  • Dispositions supplier non-conforming, analyzing trends and initiating Corrective Action as needed
  • Supports suppliers in their FMEA, Process Capability, and DOE efforts
  • Works with Suppliers on cost reduction and/or quality improvement efforts using Lean and Six Sigma initiatives
  • Supports leadership on improvements to the Supplier section of the QS policies and procedures
  • Implements methods and procedures and identifies appropriate inspecting/testing methods to evaluate the precision and reliability of Supplier processes and their product
  • Supports APQP during design and process reviews, ensuring the effective transfer of product to Suppliers
  • Is a champion for Continuous Improvement with Suppliers using lean/six sigma principles while ensuring QS compliance with properly documented changes

REQUIREMENTS: 

  1. Bachelor’s degree in an engineering or other appropriate technical discipline
  2. Minimum of 4 years’ experience in Supplier Quality in a regulated environment, preferably in Medical Device
  3. Demonstrable experience in blueprint reading (GD&T a plus) with an in-depth understanding of gage selection and gage design
  4. Hands-On experience leading supplier audits, investigation and resolution to supplier non-conforming and CAPA initialization and rationalization
  5. In-depth knowledge of 21 CFR 820 and ISO 13485 is required
  6. Must be knowledgeable in CAD (e.g. SolidWorks), CAM and the Microsoft Office Suite (MS Project a plus)
  7. Must have a strong grasp on mathematical concepts with the ability to apply them to circumstances like frequency distribution, test reliability and validity, sampling theory, SPC and other related functions
  8. Preferred certifications include Lean/Six Sigma, ASQ (especially auditing) and ISO
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