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.
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
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