Senior Quality Assurance Engineer
Company: Pivotal Integrated HR Solutions
Location: Pawtucket
Posted on: May 7, 2022
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Job Description:
Our client is an international powerhouse in the medical device
space that specializes in acute critical care and resuscitation
products. They are currently looking for a Quality Assurance
Engineer. In this role, you will be responsible for supporting the
electrode product and process sustaining activities through the
application of Quality engineering skills for medical devices. This
position focuses on process, equipment, design verification and
validations, working with teams to develop manufacturing and
quality processes and define their related tools, resolve
validation strategy, and review and approve validations. To be
considered for this position, you must have a minimum of four-year
degree in a technical discipline and a minimum of 5 years of
medical device experience. In addition, you must have knowledge of
ISO 13485. Responsibilities: Review and approval of verification
and validation protocols and reports Participate in Change Control
review and approval activities as required Provide technical
guidance to QA and QC personnel Participate in Risk Management
process, including the development and maintenance of risk
management files, ensuring compliance with ISO 14971 Develop and
implement Quality Plans Ensures post-market surveillance reviews
are conducted and reports documented according to schedule
Participate in CAPA efforts, and apply systematic problem-solving
methodologies identifying, prioritizing, communicating, and driving
resolution of quality issues Provide key quality trending
information and data for Management Review and monthly KPI review,
as applicable Requirements: Four Year degree, preferably in a
technical discipline and minimum 5 years of medical device
experience Proficient with Microsoft Office Suite Familiarity with
the use of mechanical and electrical test equipment Knowledge of
commonly-used concepts, practices, and procedures related to
medical device manufacturing Working knowledge of EN ISO 13485, ISO
14971 and FDA QSR for Medical Devices
Keywords: Pivotal Integrated HR Solutions, Pawtucket , Senior Quality Assurance Engineer, Engineering , Pawtucket, Rhode Island
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