Description
I have an immediate opening for a Supplier Quality Engineer based in Cork. This is a permanent position with one of the leading medical device companies within the medical device industry.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 the external supply chain are capable of meeting expectations from a quality, service and cost perspective.
You will serve as liaison with suppliers 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.
Key Requirements:
- CAPA experience
- Strong Audit Experience (Vendor and External)
- Project Management Experience
- Understanding of validation
Responsibilities:
* Take the quality lead role in working with suppliers on existing process improvements to develop supplier's processes, process validations and ensure the necessary process controls and documentation.
* Partner with Supplier Quality Auditing Team and Strategic Sourcing participating on pre and post audit activities and addressing audit non conformities initiated as results of supplier's audits. You will drive supplier improvement activities and to eliminate product quality issues and compliance gaps at the supplier base.
* Lead quality issues with suppliers; work with internal customers to ensure internal containment and corrections/corrective actions are implemented. Lead effective containment and corrections/corrective actions with suppliers.
* Conduct trend analysis on key performance metrics related to supplier's non conformities as results of audits, complaints and receiving inspections. Present metrics to Global Supplier Quality Management Team and internal business partners and evaluate further actions as required to deliver measurable improvement in performance of suppliers
* Lead, track and monitor Supplier Change Requests by working with internal business partners on the decisions to accept and approve the requested change. Ensure appropriate communication with the supplier and lead all deliverables from the supplier as a result of the requested change
* Ensure Regulatory compliance in the area of responsibility to GMP of all medical devices regulatory agencies and participate in external audits.
* Lead and own the control of quality content of the Approved Supplier List, support SQM partners and Strategic Sourcing in the supplier approval and add / deletion process.
Own global supplier quality metrics and input data for internal and supplier
* scorecards and participate during business reviews (internal & supplier). This includes the management and maintenance of supplier information files.
Partner with SQM functions and Strategic Sourcing on the developments and approval quality assurance agreements with suppliers
Requirements:
* 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.
If you are interested in hearing more about this fantastic opportunity with a great company please apply directly to this advert or contact Derek Sheridan on for further information.
Ref:globalsqe