Supplier Quality Engineer

Cork City  ‐ Onsite
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Description

Fortune 500 medical technologies firm based in Cork is seeking a Supplier Quality Engineer to join their team within their brand new state of the art manufacturing facility in Cork.

About the Company

This award winning company has a huge presence in Ireland. It is an exciting growth phase for this organisation and there are presently major expansion operations underway. Being part of this organisation at this time will provide you with a sense of achievement and opportunity to really make an impact.

About the Role

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 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. You will be responsible for activities including, but not limited to the following:

* 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:

For this job the ideal candidate will have a Bachelor's Degree in Engineering or Science fields and 7 years' experience in manufacturing environment. It is preferable that the candidate possess a good knowledge with GMP, ISO 13485, 21 CFR Part 820 standards. A working knowledge of FMEA, Validation Programs and SPC processes in a highly regulated environment is also desirable. A good knowledge of lean tools and concepts and experience of demonstrating a working knowledge to influence positively the trend of the relevant supplier quality metrics is also advantageous.

Other attributes that will set the ideal candidate apart include strong analytical and problem solving capabilities, the ability to plan, organize and implement multiple concurrent tasks, strong communication skills and an ability to work in cross-functional team environments. The desired candidate will also be willing to travel in support of business needs to different geographical locations.

Some of the professional requirements that are desired include:

* Preferred industries are aviation, aerospace, automotive and defense

* 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

Supplierquality

No CV? Not Sure Yet? Give me call for more info and an opportunity to ask more questions Barry Smyth !
Start date
04/2016
From
Real Staffing
Published at
16.03.2016
Project ID:
1092292
Contract type
Permanent
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