Description :
Overview :
This position reports to the Supplier Quality Assurance Manager and is responsible for working with assigned suppliers to implement the requirements of the Company's supplier quality management program.
Responsibilities :
·Auditing, monitoring, evaluating, reporting and improving supplier quality system performance and providing technical support to suppliers as determined by management.
·As required, coordinating component and product quality testing for purposes of supplier qualification and improvement.
·In depth knowledge of GR&Rs, FAIs, Capability Studies and Control Plans.
·As requested and approved, coordinating with other Bard Divisions to perform quality assessments on common suppliers to minimize costs to and burden on the suppliers.
·Supporting the Company's manufacturing sites as requested and approved in the assessments of their respective supplier quality systems for those suppliers designated within the scope of their supplier quality management responsibilities.
·Working closely with the Purchasing Department in managing the Supplier Base.
·Identifying and appropriately implementing statistical engineering tools and techniques to evaluate and implement supplier process capability and technical performance.
·Evaluating supplier quality systems and strategies compliant with regulatory requirements.
·Collecting and analyzing Quality data relating to Supplier Quality. Identifying and defining correction action required initial corrective action with responsible function and follow-up to assure completion and effectiveness.
·Communicating potential for changing supplier quality risk to the Company's management.
·Providing supplier quality engineering management to support new product design projects as required.
· Travel is required.
Qualifications :
·Bachelor's Degree required in Engineering or other technical discipline required.
·Minimum of 2 to 5 years experience in a supplier quality/supplier auditing capacity or equivalent quality function..
·Demonstrated ability to apply statistical quality engineering tools in a supplier environment.
·Preferred working knowledge of medical device manufacturing systems and FDA regulations.
·Effective communication and conflict resolution skills.
·Effective problem solving techniques.
·Six Sigma Black Belt/Lean Manufacturing experience preferred.
·ASQ-CQE, CQA preferred.