Manager, Quality Assurance
Our client, a global biomedical company focused on the development and commercialization of blood management products, is currently seeking a Manager of Quality Assurance to join their state-of-art facility in Pittsburgh. This person will be responsible for the development of QA strategies to support product line growth and driving operational excellence initiatives to improve year over year productivity.
Responsibilities Include:
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Manages multiple Global Quality Systems functions including but not limited to Non-Conforming Events, CAPAs, Document Control, Quality Systems Metrics and Global KPIs.
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Works with management to ensure the effective implementation and maintenance of Quality System requirements and procedures, to domestic and international regulations and standards.
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Participates in 2nd party agreements (e.g. contract manufacturing, distribution, acquisitions, etc.) through due diligence activities of quality system assessment, contractual agreement, and quality system integration.
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Supervisory responsibilities, including interviewing, hiring, training and developing employees; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
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Effectively manages the deployment of business strategies, the utilization of personnel, and the scope and timeliness of responses.
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Builds strategic relationships to further Quality organizational objectives and collaborates with all levels in executing quality objectives.
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Oversees the quality system compliance through Global Key Performance Indicators to monitor performance of key elements of the quality system.
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Assists management with objective evaluation of overall the Global Quality System performance and provides guidance for implementation of improvements, corrective and preventive actions for related quality processes.
Requirements:
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Bachelor’s Degree in Engineering or Life Sciences and 7+ years related quality assurance experience.
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2+ years managerial experience
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Experience in the medical device or pharmaceutical industry required
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Working knowledge of ISO 13845:2016, FDA 820 CFR, MDSAP, JPAL, CMDR, MDR, & ANVISA strongly preferred
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IVD or Single-Use experience strongly preferred
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Experience analyzing and summarizing large data set projects using valid statistical practices within the Engineering Quality System, Minitab preferred
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Analytical chemistry or biochemistry knowledge, preferred
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Lean auditor certification, preferred
If you are interested in this position, please send your resume to [email protected]
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