- Experience Level
- Experienced (non-manager)
Hobson Prior are seeking a Design/Quality Consultant join a top medical technology company who are determined to make healthcare better by delivering pioneering products and services within a variety of therapeutic areas. This position will be on a contract basis, located in Hertfordshire.
- Responsible to develop quality assurance documentation to support regulatory submissions.
- Support quality system maintenance for the design control process by identifying and correcting deficiencies in procedures and practices.
- Participate in the design, development, manufacturing, and risk management remediation activities for EUMDR compliance.
- Manage, lead, or assist in resolving nonconformities and CAPA.
- Lead risk management activities by developing risk management plans and reports, conducting risk reviews, verifying implementation and effectiveness of risk controls.
- Contribute in design reviews by identifying risks associated with the product use and tracking how the design, documentation, and manufacturing process mitigate those issues.
- Assist the definition of design verification and validation test requirements that ensure appropriate objective evidence is available to support acceptance criteria.
- Contribute to the completion of final design verification and validation reports by providing concise conclusions with statistical validity and graphical support.
- Utilise data analysis and statistical techniques to drive appropriate risk management activities and prioritization of issues.
- You will have effective communication skills.
- Demonstrated ability to effectively work cross-functionally with other departments to drive safety and performance.
- Bachelor's Degree in science, engineering or a related discipline.
- At least 3+ years' experience ideally in a strongly regulated environment such as medical device, military or aerospace industry.
- Experience in risk management activities.
- Experience in drawing review and approval.
- Prior experience in data analysis and statistical techniques to drive appropriate risk management activities and prioritization of issues.
- Prior experience in implementing compliance regulations and standards, including 21CFR820, ISO 13485, ISO 14971 throughout the design and development process.
- Experience in the definition of design verification and validation test requirements preferred.
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.