Senior Quality Assurance Engineer
Company: ZOLL Medical Corporation
Location: Pawtucket
Posted on: February 25, 2021
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Job Description:
-- Provide technical guidance to QA and QC personnel --
Supervise personnel engaged in incoming inspection and testing
activities. -- Create, document and implement inspection criteria
and procedures. -- Participate in Risk Management activities --
Contribute to departmental effort in CAPA investigation and
completion -- Interface with other departments to provide
assistance with CAPA completion -- Represent quality interests and
concerns on project teams -- Support manufacturing, new product
development, and regulatory to ensure systems are compliant with
all internal and external requirements -- Investigate causes of
quality problems identified at incoming inspection, manufacturing
and final QC inspection, as required -- Collect, analyze and
disseminate quality data throughout the organization -- Participate
in Material Review Board activities as required -- Adhere to and
ensure compliance with Quality System SOPs, work instructions,
drawings, Good Manufacturing Practices (GMP), ISO, and FDA
requirements -- Provide support and participate in customer and
agency quality audits -- Participate in Engineering Change Order
review and approval activities as required -- Four Year degree,
preferably in a technical discipline, and 3-5 years related
experience -- Proficiency with computers/software -- Familiarity
with use of mechanical and electrical test equipment -- Knowledge
of commonly used concepts, practices, and procedures related to
medical device manufacturing -- Experience with ISO 13485, ISO
14971 and FDA QSR for Medical Devices Other Duties: Please note
this job description is not designed to cover or contain a
comprehensive listing of--activities, duties, or responsibilities
that are required of the employee for this job.
Duties,--responsibilities, and activities will be reviewed
periodically as duties and responsibilities change--with business
necessity. Essential and marginal job functions are subject to
modification. ZOLL Medical Corporation appreciates and values
diversity. We are an Equal Opportunity Employer M/F/D/V. ADA: The
employer will make reasonable accommodations in compliance with the
Americans with Disabilities Act of 1990. Posted 26 Days Ago Full
time R2723 About Us ZOLL Medical Corporation, an Asahi Kasei Group
Company, develops and markets medical devices and software
solutions that help advance emergency care and save lives, while
increasing clinical and operational efficiencies. With products for
defibrillation and monitoring, circulation and CPR feedback, data
management, therapeutic temperature management, and ventilation,
ZOLL provides a comprehensive set of technologies that help
clinicians, EMS and fire professionals, and lay rescuers treat
victims needing resuscitation and acute critical care. For more
information, visit www.zoll.com. The Asahi Kasei Group is a
diversified group of companies led by holding company Asahi Kasei
Corp., with operations in the material, homes, and health care
business sectors. Its health care operations include devices and
systems for acute critical care, dialysis, therapeutic apheresis,
transfusion, and manufacture of biotherapeutics, as well as
pharmaceuticals and diagnostic reagents. With more than 30,000
employees around the world, the Asahi Kasei Group serves customers
in more than 100 countries. For more information, visit
www.asahi-kasei.co.jp/asahi/en/. Similar Jobs Follow Us Please
click here to view the ZOLL privacy policy.
Keywords: ZOLL Medical Corporation, Pawtucket , Senior Quality Assurance Engineer, Engineering , Pawtucket, Rhode Island
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