Job Title: Senior Software Quality Assurance Specialist

Position Summary:

We are seeking a Senior Software Quality Assurance Specialist to ensure compliance with site, corporate, and regulatory requirements for equipment, automated systems, and software validation. This role plays a critical part in upholding quality standards and ensuring adherence to internal and external validation regulations, with a particular focus on BSC corporate non-device software requirements.

Key Roles & Responsibilities:

• Act as a Subject Matter Expert in equipment and automated systems validation.
• Possess a strong working knowledge of Software Validation.
• Review and approve all documentation throughout the equipment and automated systems lifecycle.
• Guarantee compliance with internal and external validation regulations, especially with BSC corporate non-device software requirements.
• Maintain and update relevant procedures to align with BSC standards and industry best practices.
• Provide guidance and support in the preparation of validation protocols, test protocols, software design specifications, and related documentation for all applications that support the quality system and equipment and automated systems.
• Collaborate on project teams to define clear specifications, assess the feasibility of concepts, and provide estimates for system designs.
• Offer guidance, training, and direction on non-device software lifecycles to staff across various functions.
• Lead in software validation, compliance, and Part 11 implementation.
• Participate in vendor audits of critical equipment vendors.
• Present pertinent documentation during both internal and external audits.

Education & Experience:

• A Bachelor's degree in a relevant STEM discipline, with a minimum of 5 years of experience, preferably in a medical device or highly regulated manufacturing environment.
• Demonstrated experience in planning and executing testing for complex applications.
• Proven success in working within a highly collaborative, matrix environment, with a track record of achieving measurable business impact.
• Strong personal accountability and the courage to drive process improvements.
• Demonstrated ability to learn quickly and enhance processes.
• Excellent verbal and written communication skills, with the capacity to collaborate effectively with team members and business partners.
• Proficiency in negotiation, influencing, and building successful relationships through collaboration.
• This position plays a critical role in ensuring the quality and compliance of our equipment, automated systems, and software validation processes, making it a key element in our commitment to maintaining the highest standards within a highly regulated environment.

 

For further information on this role in Software Testing please contact Michael Brennan on Hire@hero.ie  or 086-440 3742

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/

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