Quality Specialist
Company: US Tech Solutions
Location: Sunnyvale
Posted on: August 5, 2022
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Job Description:
Job Title: Compliance SpecialistLocation: Sunnyvale,
CA94086Duration: 11 months + extension U.S. Tech Solutions, Inc. is
an Affirmative Action, Equal Opportunity Employer. Our employment
decisions are made without regard to race, color, religion, gender,
national origin, age, disability, marital status, veteran or
military status, or any other legally protected status.
Roles & Responsibilities:
--- Ensure overall QMS system compliance with applicable regulatory
and statutory requirements--- Review and approve ECO's for
Regulatory Compliance as needed--- Establish and prepare Quality
Review Board metrics for the Regulatory Compliance group.---
Compile, monitor, and report on trending of pertinent RA/QA related
metrics, as required--- Identify areas of opportunity and support
continual improvement of the Quality Management System--- Monitors
and audits adherence to corporate policies and investigate any
violations, including coordinating investigations, audits,
conducting interviews, and preparing reports.--- Control access to,
and maintain the organization of, the Quality & Regulatory
Compliance document archive library.
Skills, Experience, Education, & Training:
--- A Bachelor's Degree in a scientific or other relevant field is
preferred.--- Certified Quality Auditor/MDSAP/ISO Lead Auditor
Certification preferred.--- A minimum of 5 years experience in
audit/compliance role in the medical device industry. FDA
inspection experience preferred.--- Applied understanding of CFR
820, cGMPs, ISO 13485, MDSAP and EU-MDR--- Experience using
statistical techniques applications--- Experience with electronic
quality systems applications like Trackwise, Agile, Windchill,
Master Control--- Familiarity with EU-MDR, MDSAP, Health Canada,
and other international regulatory requirements--- Prefer previous
software quality engineering and validation experience--- Ability
to work on virtual teams, remote management; self-directed---
Demonstrated ability to effectively lead
cross-functional/cross-site project teams ; ability to be a team
player and a partner with the cross- functional teams; be part of
the solution and demonstrate ability to use risk-based approach.---
Experience implementing, interpreting, and providing guidance on
domestic and international regulations for medical devices.---
Strong organizational, written and verbal communication skills and
the proven ability to prioritize tasks effectively in a
deadline-driven environment--- Demonstrated ability to effectively
collaborate and partner with all levels of management in corporate
and division level sites.
Keywords: US Tech Solutions, Sunnyvale , Quality Specialist, Other , Sunnyvale, California
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