Senior Manager, Design Quality Assurance - Continuous Improvement
Diabetes Youth Families
SDLC
Job Level
Senior
Tech Stack
SDLC
About the role
- Conduct validation of custom build and COTS applications
- Act as guardian of the computer validation process and work across multiple product teams, performing validation activities as per SDLC
- Oversee official validation execution runs where test automation is not available
- Conduct validation test activities where required
- For COTS applications, perform full validation cycles including review of test cases and evidence of execution runs
- Prepare Validation package, including Validation Plan and Validation Report documents and review other validation documents prepared by development teams
- Ensure a full audit trail exists for each validated system
- Look for improvements in the validation process to streamline with rapid delivery cycle
- Track and manage resolution of bugs or issues generated during validation
- Serve as the quality gateway for own deliverables; anticipate problems and mitigate impact
- Represent the company during customer audits relating to computer systems
- Work independently and collaboratively in a fast-paced, matrixed environment and liaise with Quality Management, Product Management, Engineering, DevOps and IT Operations
Requirements
- Previous experience within the medical device industry in Quality/Engineering
- Knowledge of Computer System Validation including GAMP 5, 21 CFR Part 11 and CGMP requirements
- An ability to effectively communicate ideas to your team-mates and can work as part of a team, regardless of their seniority level
- Flexible, highly motivated individual and accountable
- Third level degree but experience and proven track record of 1+ years in testing or validation of computer systems counts
- A history of having close attention to detail with a high degree of accuracy
- Experience with or an interest in modern web and mobile technologies
- Being open to change, new ways for approaching problems and breaking what works before making it
- Willingness to travel internationally as required
- Eligible applicants must already hold valid and legal work permit for Ireland (no sponsorship available)
