Getinge Job - 33839792 | CareerArc
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Company: Getinge
Location: Wayne, NJ
Career Level: Mid-Senior Level
Industries: Healthcare, Pharmaceutical, Biotech

Description

Job Functions:

  • Certified Lead Auditor with extensive auditing experience
  • Lead Auditor for supplier audits at both sites (Mahwah & Fairfield) including pre and post audit related documentation and compliance.
  • Manage the Supplier Audit Program for both sites.
  • Ensure compliance to Getinge procedures.
  • Execute and follow through from intiation to completion on findings from supplier audits.
  • Manage supplier quality performance and measurement KPIs and participate in supplier performance reviews. Enable reporting of metrics for monthly reviews.
  • Lead quality issues with suppliers and partner with internal customers. Lead effective supplier containment and corrections/corrective actions.
  • Lead efforts on improvement of quality of suppliers.
  • Drive supplier requirements and supplier performance objectives
  • Supplier Development; establish & sustain effective partnerships with suppliers, develop technical capability across both Mahwah & Fairfield sites
  • SME in Supplier Quality for external audits as needed. Ensure regulatory compliance in area of responsibility to GMP of all medical device regulatory agencies. This is applicable towards both Mahwah & Fairfield sites.
  • Experience in Corrective Action Preventive Action.
  • Ensure compliance to Supplier Audit Schedule for both Mahwah & Fairfield sites
  • Lead/provide support to other SQEs in the team for both Mahwah & Fairfield sites
  • Lead multiple phases or sub-tasks of projects or entire projects of high complexity, with results impacting on project completion for both Mahwah & Fairfield sites.
  • Develop and maintain strong relationships with internal and external stakeholders to ensure optimal performance for both Mahwah & Fairfield sites
  • Report on Key Performance Indicators (KPIs) in order to adhere to process and prevent occurrence of any non-conformity relating to product, process or system  for both Mahwah & Fairfield sites
  • Facilitate the escalation of unresolved supplier quality issues within assigned projects and suppliers
  • Ensure alignment/lead standardization efforts on supplier management processes across sites.
  • Engages interest and participation of others and has a collaborative approach to working with others
  • Proactively contributes to the team

Required Knowledge, Skills and Abilities:

  • Knowledge of the principles and practices of process validation.
  • A working knowledge of quality improvement tools and techniques.
  • Knowledge of auditing procedures.
  • Work related travel (Domestic and overseas) 10 – 25 %
  • Strong knowledge of Advanced Product Quality Planning (APQP), Production Part Approval Process (PPAP), Failure Mode and Effect Analysis (FMEA)
  • Lean Manufacturing knowledge
  • Knowledge of ISO13485/ISO45001/OHSAS18001
  • Understanding of ISO14001
  • Knowledge of measurement techniques, Metrology, Inspection Methods and Equipment
  • Understanding and interpretation of engineering drawings
  • Understanding manufacturing processes
  • Ability to work in a diverse and dynamic environment.
  • Good communication and interpersonal skills, Listening skills, Negotiation skills
  • Ability to present data effectively
  • Problem-solving skills
  • Understanding of Health and Safety practices
  • Team working skills
  • Analytical skills
  • Understanding of cost and financial impacts

Minimum Requirements: 

  • 5+ years' experience in a medical device (capital goods with electromechanical components and/or disposables) manufacturing environment.
  • Supplier Auditing Experience.
  • Minimum 5 years Supplier Quality Engineering experience.
  • Certified Lead Auditor
  • Upto 70% Travel


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