About the role:
This role centers on ensuring quality and risk management throughout the lifecycle of new product development (NPD) projects. The individual represents quality interests within project teams, leading quality engineering tasks and risk management activities such as UFMEA, DFMEA, PFMEA, and related documentation. They are responsible for reviewing design compliance, conducting statistical analyses (e.g., DOE), and initiating corrective actions when necessary. The role also involves supporting biocompatibility testing aligned with ISO10993, participating in internal and supplier audits, and validating test methods and measurement systems like Gauge R&R. Candidates for this position should possess a third-level qualification in engineering, science, or a technical field, along with a minimum of five years of experience in the medical device or pharmaceutical industries. A solid understanding of regulatory standards, including ISO 13485, ISO 14971, and related CFRs, is essential. Preferred skills include attention to detail, adaptability, strong problem-solving abilities, and excellent interpersonal skills. The role requires someone who can manage multiple projects independently while collaborating effectively in team settings and meeting deadlines consistently.

Main responsibilities will include:

• Represents quality interests and concerns on project teams.
• Leads risk management activities and owns the Quality engineering activities for NPD projects.
• Must be able to balance multiple projects and tasks, from product inception through product launch and maintenance.
• Review design control compliance requirements for NPD projects and all design elements.
• Is responsible for the development of the UFMEA & DFMEA, coordinating guidance from the other design sub-team members and supporting the development of the PFMEA.
• Performs DOE’s and other statistical analysis to support product and process optimisation or resolve causes of process variation. Initiate corrective actions as required.
• Supports assessment of Biocompatibility testing required as per ISO10993 and company procedures.
• Participates in internal audit and supplier audit programmes.
• Risk management – U/DFMEA; Risk Analysis, Risk Management File and Gauge R&R and Test Method Validation.

About you:

• Third-level Engineer / Technical / Science Qualification
• Minimum of 5 years in the medical device or pharmaceutical industry is desirable
• Familiarity with regulations including ISO 13485, CFR 11820, ISO 14971 and CMDR.
• Attention to detail and adaptability
• Dedication to excellence, flexibility
• Problem-solving techniques with excellent organization skills
• Excellent interpersonal skills with the ability to work in a team environment and work under own initiative to target and deadlines