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Abbott · 3 days ago

Nonproduct SWQA Lead

Alameda, CA

Full-time

Onsite

Mid, Senior Level

$100K/yr - $200K/yr

6+ years exp

Abbott is a global healthcare leader that helps people live more fully at all stages of life. The Nonproduct SWQA Lead is responsible for ensuring that computerized systems used in the support of the Quality System are developed, validated, and maintained in compliance with regulatory and corporate requirements, while also leading and overseeing multiple portions of the Quality System.

BiotechnologyEmergency MedicineGeneticsHealth CareHealth DiagnosticsManufacturingMedicalMedical DeviceNutritionPharmaceutical

Responsibilities

Provide Quality leadership in direct support of implementation and maintenance of the nonproduct software lifecycles

Lead, oversee or contribute to multiple portions of the Quality System, including but not limited to Master Validation Plans, Impact Assessments, Validation Plans, System Specifications, Requirements, Test Protocols, Test Reports, Trace Matrices, Summary reports, NC/CAPA, and others as needed

Completes SWQA tasks in accordance with current Quality System Requirements

Works independently with objectives given by manager, planning and coordinating own work and work of others to high-level project schedules

Reviews pre-defined deliverables/activities as identified in the SWQA Non-Product Quality Process, Company Policies, or project plans

Maintains schedules and drive to meet SWQA schedule as aligned with project(s) goals

Report unexpected events, issues or software bugs which occur during verification/validation to project team and management

Develops and maintains departmental operating procedures to ensure compliance to relevant FDA QSR, ISO guidelines, including 21 CFR Part 11 and Abbott Corporate requirements as they relate to the development, verification, validation and maintenance of computerized systems used in the Quality System as well as those used in the development of ADC software/firmware products

Ensures that appropriate procedures, controls, and disaster recovery plans are incorporated into new computerized systems

Coordinates and directs activities of contract personnel, as needed, to ensure projects come to fruition in a timely manner

Qualification

Quality AssuranceSoftware ValidationFDA QSR KnowledgeISO13485 KnowledgeISO14971 KnowledgeIEC62304 KnowledgeJiraConfluenceASQ CertificationsProject CoordinationLeadership

Required

Bachelor's Degree, preferably in Engineering, Technical Field, Life Science, or related discipline or an equivalent combination of education and work experience

6+ years' experience in a Quality Assurance or software validation experience in a medical device company

Knowledge of FDA QSR, ISO13485, ISO14971 and IEC62304