Quality Assurance Manager needed for established company

Candidate must have experience in ISO 13485 and have worked with a medical device manufacture previously to be seriously considered.
SSCOR Quality Assurance Manager Job Responsibilities
• Management Representative
• 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 company’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.
• Has extensive experience in managing a quality management system for a medical device manufacturer.
• High school degree
• Minimum 5 years of related work experience or an equivalent
combination of education and work experience.
• Taken part in at least 5 audits of a medical device company

contact Lois Martin AppleOne Thousand Oaks

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.