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Staff Engineer, Supplier Quality Compliance

Job Title: Staff Engineer, Supplier Quality Compliance
Contract Type: Permanent
Location: Limerick
Industry:
REF: 88838
Job Published: 6 months ago

Job Description

Contact: Bimi Felix
Email: bimi@hero.ie
Telephone: 091730022

Staff Engineer, Supplier Quality Compliance
Our client, a medical device company in Limerick are currently looking to recruit a Staff Engineer, Supplier Quality Compliance for their site.

Key Areas of Responsibility
  • Identify and plan training to address gaps in both skills and behaviour. Form input to performance reviews.
  • Act as liaison for customer groups on key compliance issues
  • Act as Single Point of Contact for Strategic Suppliers in a Global function
  • Provides leadership to the SQE Team being responsible for the plant metric reporting and local SME for SQ procedures & processes
  • Ownership and reporting on all quality issues associated with suppliers within the assigned commodity. Ensure all Supplier related material quality issues are effectively communicated.
  • Oversight of the supplier material related processes which include: Material Review Board to ensure Coordination of MRB activities with the business unit to ensure the timely assessment of potential non-conforming products.
  • Act as a point of Contact for supplier Quality during External Audits and Internal Audits as required.
  • Ensure Regulatory compliance in area of responsibility to GMP of all medical devices regulatory agencies (i.e. FDA, IMB, Notified bodies, etc.)
  • Develop structured communication channels with strategic sourcing, identifying responsibility by commodity / supplier.
  • Liaising with the Manufacturing and Quality groups and Business Units, in assessing and addressing material quality issues.
  • Track supplier quality performance measurement (KPI's) and participate in supplier performance reviews. Enable reporting of metrics for monthly reviews and represent the SQE team at the Monthly Business Review.
  • Oversight of the Approved Supplier List (ASL) in conjunction with the Procurement function
  • Drive continuous improvement activities focusing on supplier quality.

Requirements
Professional Requirements- Required:
  • Bachelor's Degree in Engineering or Science fields
  • Minimum of 7 years' experience in manufacturing environment.
  • Good knowledge with GMP, ISO 13485, 21 CFR Part 820 standards
  • Working knowledge of FMEA, Validation Programs and SPC processes in a highly regulated environment
  • Good knowledge of lean tools and concepts. Demonstrated the ability to apply lean concepts throughout a manufacturing operation to improve quality
  • Demonstrated working knowledge to influence positively the trend of the relevant supplier quality metrics.
  • Strong analytical and problem solving capabilities with the ability to draw insights from data quickly and to define executable actions
  • Ability to plan, organize and implement multiple concurrent tasks
  • Strong communication skills. Must demonstrate the ability to communicate up/down and across different levels of the organization.
  • Demonstrated ability to work in cross-functional team environments
  • Willing to travel in support of business needs to different geographical locations.

Professional Requirements- Desirable:
  • Preferred industries are aviation, aerospace, automotive and defines
  • A working knowledge of the Supplier NADCAP Accreditation would be desirable, with particular reference to Special Process (SP) Accreditation
  • A working knowledge of Airbus SQIP process or industry equivalent
  • Lead Quality Auditor Qualification either in AS 9100 or ISO13485, CFR820 or comparable industry standards and regulatory requirements
  • ASQ CQE/CQM/PE certification
  • Strong project management capabilities with the capacity to leverage and apply knowledge
  • Personal Competencies
  • Must be able to represent & guide the SQ teams
  • Must enjoy working in team environment and undertaking leadership tasks
  • Must demonstrate outstanding collaboration and communication skills.
  • Highly motivated and able to build close relationships internally and externally.
  • Demonstrated ability for conflict resolution and constructive competence
  • Must demonstrate multitasking skills as this individual will be responsible for multiple tasks at the same time.
  • The individual should enjoy working in a dynamic and results oriented team environment focusing on quality, compliance and customer satisfaction
For further information on this Staff Engineer, Supplier Quality Compliance role in Limerick please contact Bimi Felix on 091730022 / bimi@hero.ie
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