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Engineer Design Assurance

Employer
GI Group
Location
Hertfordshire, England
Salary
Negotiable
Start date
13 Sep 2019
Closing date
11 Oct 2019

View more

Discipline
Quality, QA / QC
Hours
Full Time
Contract Type
Contract
Experience Level
Experienced (non-manager)

Job Details

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.

Gi Group are committed to protecting the privacy of all of our candidates and clients. Following some recent changes to data protection laws we have updated our Privacy Policy. To view a copy and to help you understand how we collect, use and process your personal data please visit https://uk.gigroup.com/privacy

Company

Gi Group is one of the world’s leading staffing solutions companies, providing specialist services for the development of the labour market. Gi Group’s specialist Pharmaceutical Division supply high quality temporary and permanent staff to Pharmaceutical and Biotechnology organisations nationwide.

Gi Group’s Pharma Team can support clients onsite or remotely from Gi Group central offices and are specialists in their field with experience within the Pharmaceutical, Biotech and CRO industry.

The Group is active in the fields of temporarypermanent and professional staffing, search and selection, executive search, outsourcing, training, outplacement and HR consultancy.

Thanks to our direct presence and strategic partnerships, we operate in more than 40 countries across Europe, APAC, the Americas and Africa.

Able to serve all kinds of clients, the Group has developed strong expertise in large and multinational organisations, for which it has implemented global solutions through specialist divisions and dedicated local and international teams.

Ranked globally as one of the largest staffing firms by Staffing Industry Analysts, the Group is also a global corporate member of the World Employment Confederation (formerly CIETT).

Company info
Website
Telephone
01707 247259
Location
Gi Group - Pharmaceutical Division
James Taylor House
St Albans Road East
Hatfield
Hertfordshire
AL10 OHE
GB

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