Quality Specialist

-Minimum of 1 year experience

-Maintain and improve the document control system for accuracy, compliance, and support of product releases, regulatory needs, and customer requirements.

-Manage quality system documentation -policies, SOPS, process/product records - ensuring they're current, ISO 13485-compliant, and audit ready

-Prepare, review, process, and track changes to controlled documents with timely accuracy and proper effectivity

-Administer the full approval workflow, including issuance of new docs and secure retrieval of obsolete ones

-Edit documentation for precision and manage inventory, security, and electronic database of all control files

-Maintain quality system records for easy control and retrieval per policies, procedures, and regulatory standards

-Assist in regulatory audits and partner with quality, and manufacturing teams to keep everything aligned

All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance.