Quality Specialist

Company: US Tech Solutions
Location: Sunnyvale
Posted on: August 5, 2022

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