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Compunnel Inc. · 6 days ago
Associate Quality Systems Specialist
Rocklin, CA
Full-time
Onsite
Entry Level
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Responsibilities
Directly responsible for ensuring documents submitted to Quality are compliant to company procedures, regulatory requirements, and the quality manual.
Performs project review and audit of Device History Files (DHF’s) and technical files including stability protocols, risk management plans, post-market surveillance plans, and more.
Coordinates files upon completion of review for upload into EDMS as necessary.
Write, revise and/or review Standard Operating Procedures.
Supports internal and external audits as required.
Trains other staff members as requested.
Adhere to regulatory requirements (including cGMP), standards, procedures, and company policies.
Recommends, provides, or initiates solutions by actively providing suggestions for improvement.
Must be willing and able to work on weekends or extended hours as needed.
Review and approve quality documentation and records.
Collaborates and coordinates with internal stakeholders to identify, escalate, and resolve quality issues.
Qualification
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Required
Typically HS diploma/equivalent is required
Directly responsible for ensuring documents submitted to Quality are compliant to company procedures, regulatory requirements, and the quality manual
Performs project review and audit of Device History Files (DHF’s) and technical files
Performs review of data and records supporting the DHF while assessing for good documentation and record keeping practices
Obtains information for clarification from process owners while providing appropriate and relevant feedback
Coordinates files upon completion of review for upload into EDMS as necessary
Electronically signs as technical approver for quality on applicable documents and within the validated electronic databases
Write, revise and/or review Standard Operating Procedures
Maintain extensive knowledge of Standard Operating Procedures and policies
Supports internal and external audits as required
Understands, supports, and communicates Company mission, vision, and values
Understands and follows the requirements of the quality system
Maintains current training requirements
Trains other staff members as requested
Adhere to regulatory requirements (including cGMP), standards, procedures, and company policies
Recommends, provides, or initiates solutions by actively providing suggestions for improvement
Must be willing and able to work on weekends or extended hours as needed
Follows regulatory and standard requirements as applicable to the site, i.e. MDSAP, ISO 13485, IVDD/IVDR, and compliance to the site Quality Manual
Review and approve quality documentation and records
Collaborates and coordinates with internal stakeholders to identify, escalate, and resolve quality issues
Company
Compunnel Inc.
Founded in 1994, Compunnel Inc.
Founded in 1994
1,001-5,000 employees
H1B Sponsorship
Compunnel Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (1572)
2022 (2192)
2021 (2385)
2020 (2157)
Funding
Current Stage
Late StageLeadership Team
Andy Gaur
Founder, Chairman & CEO
Karthik Natarajan
Executive VP & CTO
Company data provided by crunchbase
