Quality System Specialist

3 weeks ago

Rocklin, United States ProKatchers LLC Full time

Job Title: Quality System Specialist

Location: 95677, Rocklin, California, United States

Duration: 12 Months


Job Description:

  • 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.


Essential Duties and 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:
  • Risk Management plans, reports, FMEAs.
  • Performance evaluation plans and reports including scientific, clinical, and analytical documents.
  • Maintain extensive knowledge of Standard Operating Procedures and policies.
  • Understands, supports, and communicates Company mission, vision, and values.
  • Understands and follows the requirements of the quality system.
  • 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.

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