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Supplier Quality Auditor

Date Posted: 12/3/2019

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Job Description

Our medical technology corporation located in Mahwah, NJ is currently looking for a Supplier Quality Auditor.

Job Description:

 * Complete risk-based audits of suppliers per our company's required cycle times to ensure conformance and compliance
* Lead timely and compliant Operations audits as required and directed by the internal audit program
* Provide compliant records for FDA, ISO, Corporate, Internal, 2nd party, and Operations audits * Ensure supplier Quality Management Systems comply with applicable FDA and ISO regulations and requirements
* Identify and write findings and observations during evaluations and drive timely closure of NCs through the CAPA system
* Ensure components, sub-assemblies, and devices meet all print specifications and applicable regulations
* Work with suppliers to quarantine all suspect and non-conforming material, as required
* Issue supplier corrective action requests, as required, and drive suppliers to identify, correct, and prevent the root cause
* Participate in supplier audits, supplier evaluation, and supplier monitoring as required
* Train and educate suppliers on GMP, regulatory requirements, and our company's expectations Responsibilities related to sustainment:
* Evaluate processes, write audit reports, write non-conformances, and store records per Document Control requirements
* Ensure a timely supply of conforming components and products to our company's through process sustainment
* Root cause analysis of processes related manufacturing defects and warranty concerns
* Communicate results of supplier evaluations to our company's stakeholders and suppliers to ensure adequate responsiveness
* Identify and communicate supplier-initiated changes and ensure the suppliers follow change control requirements
* Serve as a subject matter expert for supplier evaluations, share expertise within the division and site
* Support manufacturing transfer projects through the effective and efficient evaluation of suppliers and processes Responsibilities related to development:
* Foster strong relationships with our company's supplier-partners acting as an extended enterprise
* Complete on-site audits of suppliers' Quality Management Systems through risk-based processes audits
* Drive improvement by identifying and communicating ineffective or inefficient Quality Management System processes
* Report non-conformance and performance data to highlight systemic supplier issues
* Support the creation and execution of supplier development plans by identifying potential process improvements
* Drive continuous improvement actions within supplier processes to reduce part related defects (DMP)
* Evaluate and qualify new suppliers and advanced technology processes to support product innovation
* Support strategic sourcing decisions by identifying supplier capabilities and providing input for supplier selection
* Partner with suppliers on Quality topics: Quality System, problem solving, validation, and lean
* Communicate "lessons learned' from the supply base to R&D for incorporation into next generation designs
* Become recognized and trusted as a divisional and site auditor expert and resource


* 3 years of relevant experience in Quality, Management, or Engineering
* Experience in medical device industry preferred
* Experience working onsite developing suppliers preferred
* Experience conducting supplier audits and internal audits preferred
* Demonstrated collaboration, negotiation, and conflict resolution skills
* Demonstrated ability to lead, champion change, and execute strategies to meet goals
* Critical thinking and strong analytical skills
* Comprehends production/process controls, FDA verification/validation, problem solving, & root cause
* Comprehends quality planning tools: APQP, PPAP/FAI, FMEA, MSA, Control Pla

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Job Snapshot

  • Employee Type:Full-Time
  • Location:Mahwah, NJ
  • Job Type:Other
  • Experience:Not Specified
  • Education:Not Specified
  • Date Posted:12/3/2019
  • Contact: Eva Rowe (972) 661-0015
  • Pay Range: $0.00 - $0.00 Annually
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Job Reference: JO-1912-77912