Quality Assurance Specialist

4 weeks ago

Rocklin, United States BEPC Inc. - Business Excellence Professional Consulting Full time

BEPC has an open position for a Quality Assurance Expert I

Location: Rockling, CA

Benefits: Medical, Dental, Vision, and Life Insurance

Pay Rate: $27.00 - $30.00 Hour DOE

Shift: Mon – Fri 8:00 AM to 5:00 PM

Term: 12-month contract with possible extensions or permanency (Based on Performance)

Requirements: High School Diploma or GED / 1-year experience. / Forklift experience


Job Description:

  • Responsible for the analysis, development, and operation of quality and risk management systems.
  • Activities include developing standards for quality, documentation, and processes as well as continuous improvement and preventive activities.
  • Conducts analytics to ensure that the company's products are according to defined quality standards. IMPACT: Limited impact on others.
  • COMPLEXITY: Uses clearly defined procedures to perform basic, repetitive, manual tasks. ACCOUNTABILITY/ INDEPENDENCE: Accountable for efficiency and accuracy of own routine day-to-day task execution; works under close supervision with little autonomy.
  • EXPERIENCE: Does not require any formal training or prior experience other than training-on-the-job. ORGANIZATION: Typically reports to a manager role or Project Manager role (for a defined period) based on organizational set-up and will have a lead person for day-to-day guidance.
  • Entry level position, no prior knowledge or previous experience required.
  • HS diploma/equivalent is required.


PRIMARY OBJECTIVE OF POSITION:

  • 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.
  • The position prepares Quality System documents and reports as needed for Rocklin site metrics and management review.


JOB 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 (DHFs) and technical files including:
  • Stability protocols and reports
  • Summary of Safety and Performance reports
  • Risk Management plans, reports, FMEAs.
  • Post-market surveillance plans and reports
  • Performance evaluation plans and reports including scientific, clinical, and analytical documents.
  • Product composition reports
  • Sensitivity and specificity/Repeatability and reproducibility reports
  • Specification reports
  • General Safety and Performance Requirement report Etc.
  • Review 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 sign 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.

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