Manager, Supplier Quality Assurance - medical devices

US-NH-Merrimack
6 days ago
Job ID
2017-5811
# Positions
1
Experience (Years)
8
Priority
Normal
SECURITY CLEARANCE
NONE

Overview

KMC Supplier Quality Assurance Lead – primary responsibility will be to establish, manage, and maintain the KMC Supplier Quality program including managing the KMC Supplier Approval and Assessment Process. Contributor to the selection and qualification of suppliers, includes conducting Supplier Audits and Managing the ASL. Develop purchasing control processes, procedures and systems in compliance with applicable medical device regulations. Owns supplier audit, monitoring, and assessments. Work closely with Sourcing colleagues in supplier selection/assessments, and Supplier classification and risk categorizations.

 

Actively monitors supplier quality agreements with critical suppliers and quality of supplier records and drives supplier quality management reviews with relevant stakeholders

Supplier Monitoring and Scorecard Tracking and reports supplier related metrics to ensure compliance with performance criteria and pursues corrective actions as required.

Handling and Coordination of the NCMR – MRB process controls and communication actions including SCARS with Suppliers.

Responsibilities

  1. Manage the Supplier Management Process
  2. Manage the SCAR process and establish SCAR escalation criteria
  3. Provide sufficient training to the organization regarding Supplier Quality Items
  4. Define and manage a risk based Supplier Quality Audit Program
  5. Support Sourcing and NPD in selection of new suppliers and qualification of new parts
  6. Management of Supplier Quality Assurance Resource(s)
  7. Participate in QMS Process Improvements/Lean Activities
  8. Supplier Quality Data Analysis:
  9. Collect, analyze, interpret, and summarize supplier quality data & reports (trend quality performance, supplier escalations, SCARs, and adherence to Supplier Quality Agreements)
  10. Track follow up of Supplier Audit Corrective Actions
  11. Track leading indicators with Suppliers for proactive improvements
  12. Maintain computerized collection and tracking of relevant supplier quality data as to assure fulfillment of safety and quality requirements
  13. Provide supplier related support to Procurement and Strategic Sourcing
  14. Monitor, evaluate and report on supplier compliance and qualification metrics to assure that a suitable supplier quality system is maintained.
  15. Other duties as assigned

Qualifications

The ideal candidate will have 10 years relevant FDA QMS/Supplier Quality experience and a Bachelor’s degree in related field. Prior FDA and/or ISO 13485 experience is a must.

Ability to establish strategic Q&R programs and develop and implement plans efficiently and effectively. ASQ Certified Auditor preferred.

 

  • Minimum of 25-50% travel first 18 months with less travel (15-25% thereafter).
  • Ability to travel both internationally and domestic
  • Analytical problem solving skills, experience with LEAN
  • Experience with Root Cause Analysis and Driving Corrective Actions
  • Risk mitigation experience
  • Aptitude with process validations in regulated setting
  • Adept at auditing and report writing
  • Successful process/project implementations
  • Prior experience managing remote employees, or those that travel frequently
  • Excellent organization, prioritization, and dedication to follow through on commitments
  • Ability to work in a highly regulated environment

     

     

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