Job Details
Posted 28 April, 2026
Job Id: 627331
Design Assurance Quality Lead – 1 year FTC
Job Description
About the company
This organisation is a global medical technology manufacturer operating in a highly regulated environment. The Wexford site is both a manufacturing location and home to a research and development team, supporting the design and delivery of complex medical devices.
About the role
This role leads the Design Quality function on site. The focus of the position is on design assurance, risk management and quality engineering support across new product development and product introduction activities.
The role covers a long term leave with a strong likelihood of extension and offers exposure to both R and D and manufacturing in a regulated medical device environment.
Key responsibilities
* Lead and manage Quality Engineering direct reports including hiring, performance management, training and development
* Own and maintain product risk management files in line with regulatory and internal quality system requirements
* Plan and allocate Quality Engineering resources across NPD and NPI programmes
* Provide quality engineering support for design verification and validation, test method validation, reliability testing and statistical analysis
* Oversee component qualification, equipment qualification, process capability studies and process validation
* Ensure effective application of risk management activities throughout the product development lifecycle
* Support post market activities including field assurance investigations where required
* Partner closely with R and D and Engineering to enable robust design transfer and product launch execution
* Review and approve validation documentation and risk management files
* Support regulatory, corporate and third party audits
* Contribute to additional site and business projects as needed
Required background
* Degree in Engineering or a related technical discipline
* At least seven years experience in R and D, product development or engineering within a highly regulated environment
* Minimum of three years experience in Design Assurance Quality with medical devices strongly preferred
* Proven people management experience with at least two direct reports
Technical experience
* Strong working knowledge of ISO 13485, ISO 14971, MDR and 21 CFR requirements
* Hands on experience with design, process, equipment, test method and software validation
* Practical use of quality engineering tools including risk management, root cause analysis, statistics and process capability
* Experience supporting products through development into commercial manufacture
* Experience supporting and participating in quality and regulatory audits
Personal attributes
* Confident and accountable leader with a hands on approach
* Comfortable operating in a fast paced development and manufacturing environment
* Strong collaboration and stakeholder management skills
* Clear and effective communicator
* Structured problem solver with strong analytical ability
* Self motivated, adaptable and improvement focused
Equal Opportunity Employer
We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert
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