Senior Engineer, Supplier Quality Compliance
Our client, a medical device company in Cork are currently looking to recruit a Senior Engineer, Supplier Quality Compliance for their site.
- Working in partnership with the Global Supplier Network, you'll be involved in the ongoing support for the internal business units to address ongoing supplier quality issues, development of suppliers and ensuring that our external supply chain are capable of meeting expectations from a quality, service and cost perspective.
- You will serve as liaison between suppliers and the company to drive effective continuous improvement as a result of the supplier base. You will work with internal customers and suppliers in support of supplier quality issues; provide technical support for activities related to supplier quality system assessment and performance evaluation.
- You will collaborate with the strategic sourcing, auditing and development groups to understand the capabilities and competencies of suppliers to meet our requirements and continually meet and adapt to our product quality and regulatory requirements.
- This role will provide coaching and guidance to the SQE team to ensure compliance to technical, regulatory and company requirements. This person will also act as the Single Point of contact for communication of issues for the suppliers within their commodity alignment.
- Technical understanding of manufacturing prints and tolerancing
- Knowledge in statistics
- Strong communication skills
- Strong problem solving skills
- Strong team player
- Good understanding and ability to work with Microsoft Office
- Basic understanding of manufacturing processes
- Fluent in written & oral English
- Mobility to international assignments
- Willing to travel in support of business needs to different geographical locations
- Basic understanding of project management
- Demonstrated interpersonal skills
- Ownership for supplier quality performance and measurement including KPI's and participate in supplier performance reviews. Enable reporting of metrics for monthly reviews
- Lead quality issues with suppliers & partner with Internal Customers; Lead effective supplier containment and corrections/corrective actions
- Act as point of contact for Internal/ External Customer groups on key compliance issues related to assigned suppliers
- Participate in External Audits and Internal Audits as needed. Ensure Regulatory compliance in area of responsibility to GMP of all medical devices regulatory agencies (i.e. FDA, IMB, Notified bodies, etc)
- Responsible for accuracy and integrity of supplier data that ensures compliance with documented procedures & processes
- Ownership and reporting on all quality issues associated with the assigned suppliers. Ensure all assigned supplier related material quality issues are effectively communicated to key stakeholders
- Participate in 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.
- Maintain structured communication channels with strategic sourcing, identifying responsibility by commodity / supplier.
- Liaising with the Manufacturing and Quality groups, in assessing and addressing material quality issues with assigned suppliers.
- Maintenance of the Approved Supplier List (ASL) in conjunction with the Global Sourcing, Supplier Controls and Audit functions
- Deliver continuous improvement activities focusing on supplier quality
- Participate as required in SCRB in conjunction with key stakeholders
- Support assessment of supplier changes
- Participate in supplier audit program - planning, execution and closure
- Participate in supplier reviews for assigned suppliers as required
- Participate in cross functional projects both locally & globally as required
- Partner with SQM functions and Strategic Sourcing on the developments and approval quality assurance agreements with suppliers.
Professional Requirements- Required:
- Bachelor's Degree in Engineering or Science fields
- Minimum of 2 years' experience in manufacturing environment or equivalent.
- Good knowledge with GMP, ISO 13485, 21 CFR Part 820 standards
- Good knowledge of FMEA, Validation Programs and SPC processes in a highly regulated environment
- Demonstrated working knowledge to positively influence supplier quality performance
- 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/ influencing skills. Must demonstrate the ability to effectively 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.
- Good knowledge of continuous improvement methodologies
- Preferred industries are medical device, aviation, aerospace, automotive and defines
- Internal Quality Auditor Qualification either in AS 9100 or ISO13485, CFR820 or comparable industry standards and regulatory requirements
- Must enjoy working in team environment
- Must demonstrate strong collaboration and communication skills.
- Highly motivated and able to build close relationships internally and externally.
- Demonstrated ability to prioritize and deliver against timelines
- 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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