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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