Senior Design Control, Software Quality Engineer (Medical Devices)

About the position

This position works out of our Alameda, CA office and is responsible for ensuring that Abbott and Lingo product software and computerized systems used in the support of the Quality System are developed, validated and maintained in compliance with regulatory and corporate requirements. This is an individual contributor position which may have responsibilities to monitor and direct the work of contractors/temporaries.

Responsibilities

• Participates as a member of the project team for Lingo products that incorporate software/firmware into their system.
• Completes SWQA tasks in accordance with current Quality System Requirements.
• Works independently with objectives given by SWQA Manager.
• Can plan and coordinate own work according to higher-level project schedules.
• Reviews pre-defined deliverables/activities as identified in the SWQA Product Quality Process/project plan or equivalent project plan.
• Ensures that deliverables and activities are in compliance with current Software/SWQA processes in the development of Lingo software/firmware products.
• Ensure documentation accuracy, clarity, consistency, completeness and compliance for multiple projects including System Specifications/Requirements documents, Verification Test Cases, Verification/Validation protocols, Trace Matrices and Verification/Validation Summary Reports.
• Report unexpected events, issues or software bugs which occur during verification/validation to project team and management.
• Ensures Device History File (DHF) and Device Master Record (DMR) are in compliance with regulatory standards and quality management policies and procedures.
• 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.
• May Develop and maintain Validation Master Plan(s).

Requirements

• Bachelors degree, or equivalent experience, in a scientific, technical, or engineering discipline.
• Must have 5+ experience in Software Quality Assurance.
• Knowledge of medical device standards including FDA QSR, ISO 13485, ISO 14971, 21 CFR Part 11 and IEC 62304. In particular, has knowledge of Design Control requirements.
• Must have excellent oral and written communication skills.

Nice-to-haves

• Knowledge of Jira, Confluence, ALM Quality Center, and/or other software development and test tools is a plus.
• ASQ CQE and/or CSQE Certifications a plus.

Benefits

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• 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.
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.