Job Description
Design Assurance Engineer – Farnham, England (Hybrid) – €55,000 - €65,000
Are you an experienced Design Assurance Engineer looking for an exciting new opportunity? We’re working with a leading wound care medical device business that specialises in high-quality manufacturing and innovation. They are currently seeking a skilled Design Assurance Engineer to join their growing team in Dublin, where you’ll be involved in the full end-to-end process from design concept to contract manufacturing.
About the Role: As a Design Assurance Engineer, you will play a vital role in the Design Assurance Department, overseeing every stage of the design and development process. Working closely with the QARA Director, you will be responsible for ensuring that products meet the highest quality standards and regulatory requirements. You’ll be involved in numerous projects simultaneously, helping to drive them forward and ensuring the team delivers on time and to the highest standards.
Key responsibilities include:
* Leading Documentation & Risk Assessments: Overseeing the documentation process and performing thorough risk assessments at every stage of the development cycle.
* Reviewing & Developing Protocols: Reviewing and developing design protocols, validation plans, and technical files, ensuring compliance with regulatory standards.
* Risk Mitigation: Identifying, assessing, and mitigating risks across the design and manufacturing process to maintain product safety and compliance.
* Managing Customer-Facing Activities: Handling labelling, timelines, and customer communications, ensuring that all external interactions are managed professionally and in line with the company’s high standards.
* Preparing Summary Reports: Creating detailed summary reports to track progress and ensuring all design assurance activities align with internal and regulatory standards.
* Trace Stability: Ensuring product traceability throughout the development process to maintain complete compliance with relevant regulations.
* Compiling Technical Files: Managing and compiling comprehensive technical files, ensuring all necessary documents are prepared and available for audits and regulatory submissions.
* Collaboration Across Teams: Working closely with the test and quality departments to ensure smooth project delivery and to address any quality concerns in real-time.
* Project Management: Overseeing multiple projects simultaneously, ensuring each one meets deadlines and quality expectations while managing risk and compliance effectively.
Long-Term Career Growth: This is a unique opportunity within a small, growing team, which means you’ll have the real chance to branch off and build your own team in the medium to long term. There’s strong potential for leadership and team growth as the company expands.
We look forward to hearing from you!
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