Job Summary:
A Senior Software Quality/Validation Engineer is required to ensure the quality and compliance of computerized systems in a regulated medical device industry.
Responsibilities:
* Lead validation and operational management of computerized systems to ensure compliance with industry standards and regulatory requirements.
* Develop, review, and approve comprehensive validation documentation.
* Conduct software compliance assessments and ensure adherence to regulatory frameworks and quality standards.
* Oversee 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.
* Serve 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:
* Relevant third-level qualification in Engineering, Manufacturing, or Science; master's degree a plus.
* Minimum 5 years of experience in software validation within the medical device industry or similarly regulated environment.
* Strong knowledge of regulatory frameworks, including 21 CFR Part 11, 21 CFR 820, ISO 13485, and Data Integrity standards.
* Proven experience with validation methodologies, 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 guiding teams, managing stakeholders, and driving compliance initiatives 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.
* Growing business with numerous pathways for professional growth.
* Additional benefits tailored to support employee well-being and success.