Job Title - Quality Systems Specialist
Job Location - Rocklin, CA
Job Duration - 12+ Months (Possibilities of extension)
Pay rate: $28 - $30/hr. on W2
Job description:
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:
o Stability protocols and reports
o Summary of Safety and Performance reports
o Risk Management plans, reports, FMEAs
o Post-Market Surveillance plans and reports
o Performance evaluation plans and reports including scientific, clinical, and analytical documents.
o Product composition reports
o Sensitivity and specificity/Repeatability and reproducibility reports
o Specification reports
o General Safety and Performance Requirement reports
o Etc.
Performs review of data and records supporting the DHF while assessing for good documentation and record keeping practices ensuring appropriate requirements are met.
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.
Other duties as assigned or required.