Senior Software Quality Engineer

Job title:

Senior Software Quality Engineer

Company:

Collins McNicholas

Job description

Our client, a global leader in the medical device industry, is seeking a highly skilled and experienced Senior Software Quality/Validation Engineer to join their team. This senior role focuses on ensuring the quality and compliance of computerized systems while contributing to innovation in a regulated, high-impact industry.Responsibilities:

• Lead the validation and operational management of computerized systems to ensure compliance with industry standards and regulatory requirements.
• Develop, review, and approve comprehensive validation documentation, including validation protocols, reports, and risk assessments, in line with 21 CFR Part 11, Data Integrity, and company policies.
• Conduct detailed Software Compliance Assessments, ensuring adherence to regulatory frameworks and quality standards.
• Oversee developing and maintaining quality-related procedures, work instructions, and system documentation to uphold compliance and operational excellence.
• Drive continuous improvement by identifying trends, reporting metrics, and implementing initiatives to enhance system validation processes.
• Act as a liaison between cross-functional teams to ensure alignment on validation strategies, quality goals, and compliance initiatives.
• Present validation status updates, key performance metrics, and improvement plans to senior leadership.
• Mentor junior team members and provide expert guidance on software validation practices, regulatory requirements, and quality management systems.

Qualifications and Experience

• A relevant third-level qualification in Engineering, Manufacturing, or Science; a master’s degree is a plus.
• Minimum of 5 years of experience in software validation within the medical device industry or a similarly regulated environment (e.g., pharmaceutical or biotechnology).
• Strong knowledge of regulatory frameworks, including 21 CFR Part 11, 21 CFR 820, ISO 13485, and Data Integrity standards.
• Proven experience with validation methodologies (e.g., IQ/OQ/PQ), risk management, and traceability practices.
• Demonstrated ability to manage multiple projects and priorities in a fast-paced, regulated environment.
• Exceptional analytical, communication, and organizational skills with a detail-oriented mindset.
• Leadership experience in guiding teams, managing stakeholders, and driving compliance initiatives is desirable.

Benefits

• Comprehensive family health insurance
• Excellent pension scheme
• Life assurance
• Career development opportunities in a global organization
• Access to a state-of-the-art facility and innovative projects
• A growing business with numerous pathways for professional growth
• Additional benefits tailored to support employee well-being and success

For a confidential discussion and more information on the role, please contact Kevin Griffin.(021) 2427108

Expected salary

Location

Kilkenny

Job date

Tue, 07 Jan 2025 23:25:53 GMT

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