Job Description:

Roles that are 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 of time) based on organizational set-up, will have a lead person for day-to-day guidance. Entry level position, no prior knowledge or previous experience required. Typically, 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:

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:

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 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.