Supplier Quality Manager - Mahwah, NJ in Mahwah, NJ at Getinge

Date Posted: 8/5/2018

Job Snapshot

  • Employee Type:
  • Location:
    Mahwah, NJ
  • Experience:
    Not Specified
  • Date Posted:

Job Description

Position Overview:

This position has the responsibility for leading the Fairfield/Mahwah Supplier Quality program and executing associated systems, processes, programs/initiatives, practices, and metrics for ensuring and improving overall Supplier Quality performance. This position partners with Quality leaders as well as representatives from Sourcing/Supply Chain, R & D, Operations and other functions to lead and collaborate on Supplier Quality Management improvements. Develops and manages the department to assess and ensure compliance to the FDA Quality System Regulations CFR Part 820, ISO 13485 Quality System Standard, MDD, CMDR. WHLW, ANVISA, JPAL and other applicable regulations. Manages the Fairfield/Mahwah supplier audit program and maintains supplier audit reports, supplier qualification documentation and supplier certifications. Leads the supplier quality team and coordinates efforts to evaluate, select, qualify, rate, monitor and improve supplier quality.

Job Details:

  • Collaborates with the supply chain management team, quality control, engineering, R&D and regulatory to establish guidelines for supplier quality and performance.
  • Ensures that supplier quality personnel maintain the required skill level to address compliance issues and to understand the technical aspects of compliance. 
  • Leads any product/process transfers of suppliers or to & from in house to suppliers. Manages the Pre-Production Approval Process (PPAP).
  • Represents Supplier Quality performance internally and externally including during the interactions with regulatory agencies and suppliers.
  • Provides support in investigations and reports on supplier corrective actions and timeliness including NCR’s, SCARS and supplier related CAPA’s.
  • Responsible for ensuring that training is completed for direct reports per established time lines.
  • Develop risk based programs and procedures for supplier transfers, supplier qualifications and supplier performance and productivity improvement.
  • Develop strategy for continuous supplier quality improvement.
  • Create benchmarks to measure department performance. Reports on key site supplier metrics and KPI’s.
  • Create reports that measure and track supplier quality performance to identify opportunities for improvements.
  • Oversees supplier rating program.
  • Participates in team project meetings for new product development.
  • Key member of project teams approving changes to existing products/components.
  • Plays a major role in the supplier selection process, evaluation of potential suppliers and the supplier qualification process.
  • Manages supplier audit program and participates as needed. 
  • Oversees audit/assessment of current and future suppliers ensuring compliance with requirements.
  • Oversees validations and qualifications of supplier facility to qualify manufacturing processes and overall quality of part/component manufacturing.
  • Contributes to team effort by accomplishing related tasks as necessary.

Background Experience:

  • Bachelor Degree in Engineering, Scientific or related discipline.
  • A minimum of six progressive years’ experience in a supplier quality role or equivalent position. 
  • Experience in the areas of lot acceptance sampling methodologies, MSA/GR&R, SPC and other statistical techniques.
  • Experience of administering Supplier Corrective Action Programs.
  • Audit experiences a must. CQE and/or CQA, Lead Auditor certification preferred.
  • Previous supervisory experience required.
  • Excellent working knowledge of MS Office (Word/Excel) and a statistical based software package (Minitab preferred). 

Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.