Quality Specialist III, Supplier Quality

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Employer is looking for Quality Specialist III, Supplier Quality in Middletown, NY. This local job opportunity with ID 742745 is live since 10/15/2017.
Job Description
As the Quality Specialist III you will be a member of the Clinical Diagnostics Division Quality Team at the Middletown, VA campus reporting to the Manager of Quality Systems. In this role you will be responsible for implementing and maintaining the effectiveness of the quality system; ensures systems are established, effective and maintained in compliance with regulatory, corporate and site requirements and policies related to supplier control and management and identify, leads and implements initiatives for the continual improvement of the supplier quality processes.

Position Summary:
•Manage the supplier quality program including but not limited to Supplier change notifications, supplier corrective actions and supplier qualifications.
•Develops, implements, monitors and maintains meaningful metrics to demonstrate the effectiveness of the supplier quality processes.
•Report metrics and provide input to management reviews where supplier issues are discussed advising management of potential risks and make recommendations.
•Act as Lead Auditor during supplier audits. Ensure management of supplier audits from planning to completion. Approve and monitor supplier CAPA/SCAR plans and activities to closure including objective evidence of effectiveness.
•Chair meetings to review supplier performance with other department stakeholders.
•Issue SCARs for supplier corrective/preventive action activities.
•Participate and/or lead cross functional meetings and process improvement teams related to supplier improvement.
•Participate in design changes related to supplier provided materials. Partner with Purchasing to qualify new suppliers.
•Thorough understanding of ISO/QSRs and the ability to apply the knowledge to the business to ensure compliance to the regulations.
•Travel is required – approximately 10-20% depending on status of suppliers and supplier issues.

Minimum Requirements/Qualifications:
•B.A., B.S. or M.S. in Life Sciences or an engineering discipline or an equivalent combination of education, experience and/or licensure/certification.
•The required skills, knowledge and abilities that are typically acquired through a minimum of 5 years medical device experience in supplier quality assurance.
•Knowledge of overall regulatory requirements associated with medical products into worldwide markets.
•Must have experience and knowledge of ISO 13485:2003, 21 CFR Part 820, IVD Directive and Canadian MDR.
•Communicate effectively both verbally and written with supplier and internal personnel in a professional manner. Strong writing and facilitation skills. Function with little to no supervision.
•Detail oriented and has the ability to lead multiple projects and activities assigned.
•Must have experience performing and evaluation effective root cause analysis, corrective and preventive actions.
•Must have demonstrated hands on, results oriented, multi-tasking response to the urgent needs of the company and show a strong track record of meeting deadlines.
•Lead Auditor certification (CQA/ASQ/ISO is preferred).

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Employer is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. read more