Software Quality Assurance Engineer

Job Title: Software Quality Assurance Engineer

Job Description

We are seeking a Senior Software Quality Assurance Engineer to ensure that product software and computerized systems used in support of the Quality System are developed, validated, and maintained in compliance with applicable regulatory and corporate requirements. You will join a project team for a variety of software products that incorporate software/firmware into their systems, such as Document Management, Learning Management, ERP, Manufacturing Execution, Inventory Management, and Complaints systems. You will be responsible for reviewing quality system documentation products, coordinating activities with other engineering disciplines, and estimating, planning, and reviewing work products.

Responsibilities

• Complete SQA tasks in accordance with current Quality System Requirements.
• Work independently with objectives given by the SWQA Manager or QA Director.
• Plan and coordinate own work according to higher-level project schedules.
• Review pre-defined deliverables/activities as identified in the SWQA Non-Product Quality Process and/or SWQA Product Quality Process/project plan or equivalent project plan.
• Ensure documentation accuracy, clarity, consistency, completeness, and compliance for multiple projects.
• Report unexpected events, issues, or software bugs during verification/validation to project team and management.
• Develop and maintain departmental operating procedures to ensure compliance with relevant FDA QSR, ISO guidelines, including 21 CFR Part 11 and corporate requirements.
• Ensure appropriate procedures, controls, and disaster recovery plans are incorporated into new computerized systems.
• Develop and maintain Validation Master Plans and monitor and direct the work of contractors/temporaries.
• Ensure computerized systems used in support of the Quality System are developed, validated, and maintained in compliance with regulatory and corporate requirements.

Essential Skills

• Extensive experience in Software Quality Assurance (SQA), Computer System Validation (CSV), or similar roles in Enterprise Healthcare, Medical Device, Life Sciences environments.
• Extensive experience supporting a portfolio and variety of Validated Systems such as ServiceNow, Document Management, Learning Management, ERP, MES.
• Expert/SME knowledge of CRF Part 11, FDA QSR, ISO guidelines, and the relevant Software Lifecycle.
• Strong experience with ALM and Mfiles.
• Strong communication skills, including requirement gathering and stakeholder management.

Additional Skills & Qualifications

• Experience with CFR 820 and relevant CFR regulations.

Why Work Here?

Join a highly respected Fortune 100 organisation in the growing life sciences industry. Enjoy a long-term contract position where the majority of contractors have been on-site for over 2 years.

Work Environment

Fast-paced and complex environment with high expectations, requiring attention to detail.

Job Type

This is a Contract position and It is FULLY REMOTE with a once a quarter trip to Dublin, Ireland

London, UK

Trading as TEKsystems. Allegis Group Limited. Level 1, The Chase, Carmanhall Road, Sandyford, Dublin 18, Ireland. No. 909257. TEKsystems is a company within the Allegis Group network of companies (collectively referred to as "Allegis Group"). Aerotek, Aston Carter, EASi, Talentis Solutions, TEKsystems, Stamford Consultants and The Stamford Group are Allegis Group brands. If you apply, your personal data will be processed as described in the Allegis Group Online Privacy Notice available at our website.

To access our Online Privacy Notice, which explains what information we may collect, use, share, and store about you, and describes your rights and choices about this, please go our website.

We are part of a global network of companies and as a result, the personal data you provide will be shared within Allegis Group and transferred and processed outside the UK, Switzerland and European Economic Area subject to the protections described in the Allegis Group Online Privacy Notice. We store personal data in the UK, EEA, Switzerland and the USA. If you would like to exercise your privacy rights, please visit the "Contacting Us" section of our Online Privacy Notice on our website for details on how to contact us. To protect your privacy and security, we may take steps to verify your identity, such as a password and user ID if there is an account associated with your request, or identifying information such as your address or date of birth, before proceeding with your request. commitments under the UK Data Protection Act, EU-U.S. Privacy Shield or the Swiss-U.S. Privacy Shield.