Quality Assurance Specialist

3 days ago


Rocklin, California, United States Experis Full time
Job Summary:

The Associate Quality Systems Specialist will be part of the Quality team and responsible for providing quality support for the site quality management system.

This position ensures compliance of the quality system with regulations relevant to the business, including but not limited to, ISO13485, MDSAP, IVDD/IVDR, CFR 21, GxP, and the quality manual.

This position is multi-disciplinary with opportunities to work on future products and current product and process improvements.

The position may represent Quality on cross-functional teams to support business needs driving a positive site quality culture.

Key Responsibilities:

  • Prepare Quality System documents and reports as needed for Rocklin site metrics and management review.
  • Ensure submitted documents comply with company procedures, regulatory requirements, and the quality manual.
  • Review and audit Device History Files (DHFs) and technical files, including stability reports, risk management plans, product composition, performance evaluation, and safety reports.
  • Assess data and records for proper documentation and record-keeping practices.
  • Coordinate file uploads to EDMS; act as technical approver for quality documents.
  • Write, revise, and review Standard Operating Procedures (SOPs).
  • Support internal/external audits and maintain knowledge of SOPs and policies.
  • Provide training, follow quality system requirements, and ensure compliance with regulatory standards (cGMP, ISO 13485, IVDD/IVDR).
  • Collaborate with stakeholders to address quality issues and offer improvement suggestions.

Requirements:

  • Preferred: Bachelor's degree in any life science, GMP, Pharma industry experience
  • At least 1 year of experience


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