Engineer Design Assurance

GI Group
Hertfordshire, England
13 Sep 2019
11 Oct 2019
Allison Skeggs
Quality, QA / QC
Full Time
Contract Type
Experience Level
Experienced (non-manager)

Engineer Design Assurance
Elstree, Hertfordshire
Full time - contract position

Are you seeking to develop your career with a global medical device company who develop innovative products and services that ultimately improve the lives of patients? We are looking for an experienced professional to lead design control and risk management processes for EUMDR compliance. Work cross functionally to drive our company's mission and strengthen the Stryker Brand. Provide guidance to the product development teams to ensure product compliance to the company's quality system and external standards.

Key tasks
 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.
 Manage, lead, or assist in resolving nonconformities and CAPA.
 Engage in the design, development, manufacturing, and risk management remediation activities for EUMDR compliance.
 Lead risk management activities by developing risk management plans and reports, conducting risk reviews, verifying implementation and effectiveness of risk controls.
 Participate in design reviews by identifying risks associated with the product use and tracking how the design, documentation, and manufacturing process mitigate those issues.
 Support 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.

Qualifications, skills and desirable experience
 Minimum of 3+ years' experience ideally in a strongly regulated environment such as medical device, military or aerospace industry
 Bachelor's Degree in science, engineering or a related discipline
 Experience in risk management activities.
 Experience in the definition of design verification and validation test requirements preferred.
 Experience in drawing review and approval
 Demonstrated ability to effectively work cross-functionally with other departments to drive safety and performance
 Previous experience in data analysis and statistical techniques to drive appropriate risk management activities and prioritization of issues.
 Effective communication and previous experience in implementing compliance regulations and standards, including 21CFR820, ISO 13485, ISO 14971 throughout the design and development process.

Our client is a career destination for engaged, passionate and talented people who are driven to seek the innovation, growth and opportunity. If you are keen to explore opportunities to develop your career then please apply for this position without delay.

Gi Group Pharmaceuticals provides a tailored Account Managed Service and dedicated Pharmaceutical recruitment team and partners with many different Pharmaceutical and Biotechnology clients throughout the globe and the United Kingdom.

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