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Abbott · 9 hours ago

Sr Quality Compliance Specialist

Alameda, CA

Full-time

Onsite

Mid, Senior Level

$87K/yr - $173K/yr

5+ years exp

Abbott is a global healthcare leader that helps people live more fully at all stages of life. The Sr. Quality Compliance Specialist will be critical in maintaining a state of continuous inspection readiness and ensuring compliance with applicable regulatory requirements, including ISO 13485 and MDSAP, while leading internal and external audits readiness activities.

BiotechnologyEmergency MedicineGeneticsHealth CareHealth DiagnosticsManufacturingMedicalMedical DeviceNutritionPharmaceutical

Responsibilities

Maintain and continuously improve the inspection readiness program to ensure the site is always prepared for regulatory and internal audits

Coordinate and support internal audits, including planning, execution, reporting, and follow-up on corrective actions

Serve as a support during external audits (e.g., Notified Bodies, FDA, Corporate), including logistics, documentation, and auditee coaching

Monitor and ensure compliance with applicable regulatory standards applicable to ADC (ISO 13485, MDSAP, 21 CFR Part 820, etc.)

Maintain audit schedules, records, and metrics; track and trend audit findings to identify systemic issues

Collaborate with cross-functional teams to ensure timely and effective CAPA implementation related to audit findings

Support the development and delivery of training on audit readiness and compliance topics

Participate in quality system improvement initiatives and support regulatory submissions as needed

Qualification

ISO 13485MDSAPRegulatory complianceQuality assuranceAudit experienceCommunication skillsProblem-solving skillsOrganizational skills

Required

Bachelor's degree in a scientific, engineering, or quality-related field

5+ years of experience in quality assurance or regulatory compliance in the medical device industry

Strong knowledge of ISO 13485, MDSAP, and other applicable regulations

Preferred

Experience supporting or leading audits (internal and external)

Excellent organizational, communication, and problem-solving skills

Ability to work independently and collaboratively in a fast-paced environment

Benefits

Free medical coverage for employees via the Health Investment Plan (HIP) PPO

An excellent retirement savings plan with high employer contribution

Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.