Quality Assurance Expert

*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.
Job Types: Full-time, Contract Pay: $27.
00 - $30.
00 per hour Expected hours: 40 per week Benefits: * Dental insurance * Health insurance * Life insurance * Vision insurance Experience level: * 1 year Schedule: * 8 hour shift * Day shift * Monday to Friday Education: * High school or equivalent (Preferred) Experience: * QA/QC: 1 year (Preferred) * Manufacturing Environment: 1 year (Preferred) Ability to Commute: * Rocklin, CA 95677 (Required) Work Location: In person