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Sr Quality System Manager

Company: Haemonetics Corp.
Location: Covina
Posted on: September 17, 2022

Job Description:

We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further - Haemonetics is your employer of choice.

Job Details

* Manages multiple Global Quality Systems functions including but not limited to: Non-Conforming Events, Corrective and Preventive Actions (CAPA), Training; Document Control, Management Controls including Management review and Quality Planning; Quality Systems Metrics and Trending - Global Key Performance Indicators (KPIs)

Job Description

* Effectively manages the deployment of business strategies, the utilization of personnel, and the scope and timeliness of responses. Builds strategic relationships to further Quality organizational objectives and collaborates with all levels in executing quality objectives.


  • Works to achieve the overall objectives of the company and ensures that quality strategies are aligned for the areas of responsibility.

    * Oversees the quality system compliance through Global Key Performance Indicators to monitor performance of key elements of the quality system.

    * 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.

    * Works with management to ensure the effective implementation and maintenance of Quality System requirements and procedures, to domestic and international regulations and standards.

    * Executes on the Quality System strategy and facilitates implementation.

    * 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.

    The candidate should have working knowledge of ISO13845:2016, FDA 820 CFR, MDSAP, JPAL, CMDR, MDR, & ANVISA regulations and Standards. The person should have minimum bachelors degree in life science or engineering. A minimum of 7-10 years of experience in a medical device, IVDR, Pharmaceutical or regulated industry.

    Lead Auditor Certification - Preferred

    ASQ Certification - Preferred


    EEO Policy Statement

    Conditions of Employment: Haemonetics' policy requires COVID-19 vaccination for all U.S. employees, unless approved for a medical, religious or business exemption. While we recognize employees have their own individual beliefs and perspectives regarding vaccination, we believe it is an important step as part of our obligation to protect our colleagues, our customers and our communities as we continue to make health and safety our top priority.

Keywords: Haemonetics Corp., Covina , Sr Quality System Manager, Executive , Covina, California

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