Principal Supplier Quality Engineer

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• Provide Pre-Market Quality Engineering support to New Product Development (NPD) teams, working in partnership with Medtronic cross functional teams, Contract Manufacturers and Suppliers to deliver quality parts, materials, and services, prevent defects, and allow Medtronic to provide customers with the highest quality and reliable products.
  
• Qualify & onboard suppliers according to company standards during the NPD pre-production and development phases, to ensure high product yields and reliability are achieved.
  
• Execute validation activities to ensure suppliers are meeting Medtronic requirements & ensuring high product reliability and confidence in supplier related issues as they occur.
  
• Develop and prioritize a supplier’s auditing schedule during NPD to ensure that designated suppliers are audited and onboarded to the ACM ASL per Medtronic requirements and ensuring good manufacturing practices (GMP) and quality standards are met.
  
• Evaluate suppliers' internal functions to assess their overall performance and provide feedback in assessment of their operation.
  
• Build a collaborative relationship with suppliers to quickly address any
  
• Drive appropriate root cause investigations with the supplier & ensure corrective actions are implemented and monitored for desired results.
  
• Drive supplier improvement/corrective action through the following
  
• Provide technical assistance to suppliers/other resources
  
• Work with suppliers and sub-tier suppliers, as required, to lead and drive systematic improvements and ensure stability related to medical device
  
• Define Receiving Inspection requirements and associated test method validations where required for internal Medtronic Test Methods.
  

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• Level 8 degree required in Science, Engineering, or a relevant discipline
  
• Minimum of 7+ years of relevant experience, in the medical industry or related field
  
• Experience with Process Validations and/or Test Method Validations (For Example: IQ, OQ, PQ, and/or TMV).
  
• New Product Development experience.
  
• Dynamic team player, (communications, accountability, decision-making, feedback, meeting management, managing conflict), who can work effectively and proactively on cross functional teams.
  
• Problem solving and root cause analysis for improvements or non-conformances.
  
• Experience with Agile, SAP & Microsoft Project an advantage.
  
• Excellent problem-solving skills are desirable.
  
• Good communicator and fluent in English, both verbal and written.
  

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• Knowledge of regulatory requirements and guidelines including 21 CFR parts 210, 211, 21 CFR part 820, ICH requirements and ISO 13485 requirements is an advantage.
  
• Previous experience in Supplier Quality and leading teams
  
• Experience & knowledge in Lean Principles, FTQ & DRM.
  

Medtronic offers a competitive Salary and flexible Benefits Package. xcfaprz

Pay range: Ireland: 78,320.00 EUR - 117,480.00 EUR.

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).