Sr Quality System Manager
Company: Haemonetics Corp.
Posted on: September 17, 2022
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.
* 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)
* 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
* 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
* 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
Keywords: Haemonetics Corp., Covina , Sr Quality System Manager, Executive , Covina, California
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