Medical Device Quality Assurance Specialist

Responsibilities

• Understand and ensure compliance with the Key quality system, recognizing the impact on both the customer and quality.
• Support daily tasks and documentation associated with the quality system, including Nonconformance reports, Returns, CAPAs, Deviations, and Customer Complaints.
• Conduct Compliance walk-throughs of production, testing, and warehousing areas.
• Revise and maintain documents and records for quality-related functions, update tracking logs and databases.
• Inspect incoming material to blueprints/specification sheets, complete relevant documentation, and initiate non-conforming material documentation, disposition, and corrective action documentation as required.
• Perform quality document review and approval of in-process (work orders) and finished goods (DHRs) before release, documenting all work on appropriate records.
• Support facility equipment calibration and verification program.
• Assist in developing and maintaining the Supplier Certification program, including on-site product audits and follow-up on discrepancies and corrections.
• Serve as an internal and external audit team member, responsible for planning and conducting audits as assigned, and supporting audits by external regulatory authorities.
• Assist in administrative functions of the department as necessary.
• Perform other functions as assigned by management based on department needs.

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, Los Angeles County Fair Chance Ordinance, and San Francisco Fair Chance Ordinance.