· Manage all internal, external audits and inspections

· Assist in training personnel to QMS procedures

· Closing recall files; from recall initiation to closure and maintaining recall files per FDA regulations

· Responsible for ensuring products meet safety and regulatory standards.

· Performs Post Market surveillance, document PMS activities

· Maintain DMR (Device Master Records)

· Responsible for submitting reportable events in a timely manner per applicable regulatory requirements

· Renew SSCOR’s Medical device license and registration for all applicable Jurisdictions.

· Prepare Management Review and Trend Presentations; data/quality metrics collection and trending; collect and analyze data from different sources to identify the issues

· Manage DCO (Document Change Order) process, updating documents such as procedures, inspection documents, etc. for DCO package. Update system once approved.


· Maintain Training Records

· Maintain external references and perform Gap Assessments as necessary.

· Manage and maintain the calibration system, send the measuring tools out for calibration, follow up if required, maintain the calibration records/certifications, and update the calibration system/list as needed.

· Manage DHR review; Ensure DHR reviews are performed in a timely fashion

· Reprocessing event review, prepare reports

· Manage complaint handling system. Assist in complaint handling; initiate complaints in the system, if needed, follow up with the complainant for adverse event or other required information

· Manage CAPA handling process; initiation of CAPA (Corrective and Preventative Action), introduction of CAPA to the system, send reminder to CAPA owners prior to due dates, update CAPA's as necessary

· Maintain supplier files and assist in auditing of vendors and distributors if necessary

· Manage closure of service & repair records in the system.

· Represent QA in MRB meeting preparation and non-conforming product investigation and risk analysis

· Manage Internal Equipment Preventive Maintenance System, ensuring that equipment is properly maintained and necessary records are kept

· Manage Review and Approval of production and incoming inspection records

· Track Personnel errors (shipping, repairs, incoming inspection, production, order entry)

· Manage Repair Clerk and Quality Coordinator

· Create people analyzer for direct reports.

· Identifies opportunities for continued education.

· Assist other tasks required or assigned by Executive Team

Equal Opportunity Employer / Disabled / Protected Veterans

The Know Your Rights poster is available here:
https://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12.pdf

The pay transparency policy is available here:
https://www.dol.gov/sites/dolgov/files/ofccp/pdf/pay-transp_%20English_formattedESQA508c.pdf

For temporary assignments lasting 13 weeks or longer, AppleOne is pleased to offer major medical, dental, vision, 401k and any statutory sick pay where required.

We are committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation for any part of the employment process, please contact your staffing representative who will reach out to our HR team.

AppleOne participates in the E-Verify program in certain locations as required by law. Learn more about the E-Verify program.
https://e-verify.uscis.gov/web/media/resourcesContents/E-Verify_Participation_Poster_ES.pdf

We also consider for employment qualified applicants regardless of criminal histories, consistent with legal requirements, including, if applicable, the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance. Pursuant to applicable state and municipal Fair Chance Laws and Ordinances, we will consider for employment-qualified applicants with arrest and conviction records, including, if applicable, the San Francisco Fair Chance Ordinance. For Los Angeles, CA applicants: Qualified applications with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.