Our client, a medical device company in Galway is currently looking to recruit a Supplier Quality Engineer II - Allianz Quality Management (AQM) for their site.
- Develops, establishes and maintains quality engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. Serves as a Quality representative to improve awareness, visibility, communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities. Provides focused quality engineering support within new product development, operational, or system/services support.
- Responsible for quality performance of Sourced Finished Medical Device manufacturers (OEM and Contract Manufacturers). Responsible for engaging suppliers to proactively reduce risk to patient and revenue streams. Responsible for partnering with Supplier Engineering and Commercial Sourcing to meet category strategic plans and objectives. Drives improvement and corrective action for the quality of materials sourced from outside suppliers. Provides technical and quality system support for the selection of suppliers. Monitors supplier performance to drive supplier corrective action, manufacturing yield issues and field failures
- Provides engineering support for activities related to supplier selection and evaluation, material qualification, supplier performance and receiving inspection.
- Contributes to the development, maintenance and improvements of supplier quality policies and procedures.
- Provides guidance to BSC Purchasing and Engineers in applying supplier quality system requirements.
- Reviews and approves all BSIL material and component specification drawings.
- Provides engineering guidance to Receiving Inspection technicians including statistical analysis, measurement techniques and documentation.
- Assesses supplier capabilities through direct visits, technical discussions and quality system audits.
- Contributes to and participates in Material Review Boards.
- Contributes and participates in supplier performance reviews.
- Evaluates and establishes Supplied Data Agreements (Ship to stock Programmes) with suppliers.
- Works with product line engineering to assess and address material quality issues.
- Demonstrates a thorough understanding of related quality standards, including ISO and GMP.
- Assists in establishing and implementing Supplier QA Department improvement goals.
- Evaluates in conjunction with EHS new equipment/processes/chemicals for environmental impact/effect to eliminate or lessen such impacts/effects.
- Strong team member with the ability to identify and drive quality improvements.
- Ability to work on own with minimum supervision.
- Coaches others in analysis and decision making. A source of technical guidance to Quality Engineer II, Quality Engineer I, Graduate Quality Engineer, Technician and Inspection staff.
- Excellent interpersonal and communication skills.
- Help assess potential new suppliers for technical, quality and manufacturing capabilities.
- Partnership with supplier on process improvements for capability, reduction in risk, single point failures, etc.
- Builds partnerships across the organization.
- Pro-actively communicates effectively and meets supplier/customer or team needs.
- Communicates well in group settings with other departments or disciplines.
- Consistently hits project milestones.
- Maintain and update Supplier Agreements, Complaint Management Plans, Finished Good Documents, Parts etc
- Bachelor’s Degree in Engineering, Science or Quality Assurance, (min HETAC level 8)
- 2-5 experience of Supplier Quality including demonstrated understanding of QSR and ISO standard requirements for Material/Purchasing Controls, Product Realization, Validation and CAPA
- Experience in BSC systems including Windchill, NCEP. SCAR, SCIA would be a distinct advantage as well as lead auditor experience
- The ideal candidate would have some experience in production and process controls, problem solving and have excellent communication skills.
- Excellent interpersonal and communication skills with good leadership abilities.
- Excellent analytical and problem solving skills.
- Candidates should have a proven track record of working in a fast paced environment with strong technical capabilities and be capable of handling multiple development aspects of assigned projects.
For further information on this Supplier Quality Engineer role in Galway please contact Alan Prendergast on 0860462367/ firstname.lastname@example.org
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