Device Quality Engineer - Macclesfield

CK Group
26 May 2018
15 Jun 2018
Contract Type
Full Time
Alex Tosney is recruiting for a Device Quality Engineer to work with a pharmaceutical company on medical device development and manufacturing operations based in Macclesfield. This is a contract opportunity to join a company with a broad range of human healthcare products for an initial duration of 6 months.

This role is offering an hourly rate of up to £40 per hour dependant upon experience.

As a Device Quality Engineer you will be accountable for developing and supporting new device projects (medical device and combination products) and on market support for device aspects of the existing parenteral portfolio.

Further responsibilities of this Device Quality Engineer position will be:
- Preparing Device Development documentation and ensuring its compliance with internal and external quality and regulatory requirements.
- Leading specific device development activities e.g. Risk Assessments, Design Reviews.
- Ensuring that work is performed in accordance with appropriate quality and compliance standards, e.g. QSR/ISO/MDD/GMP/GLP and SHE requirements. Prepare and maintain documentation and formal reports in accordance with these standards. Prepare formal reports and contributions to regulatory documentation.
- Assessing and reporting data with a clear understanding of its reliability, interpret findings and draw authoritative conclusions and recommendations. Establish and maintain a close working relationship with suppliers and design consultants and contribute to management of external collaborations
- Liaising with other sections in Product Development other departments (Global Marketing, Regulatory Affairs, Operations, etc.) to ensure that any proposals meet their requirements and expectations.
- Maintaining a network of contacts across Pharmaceutical Development and other key groups. Contribute to the internal networks in the Device/Medical Device area
- Managing device and packaging aspects of development projects or support elements of complex projects to achieve project targets in a timely fashion and to agreed quality standards. Plan and review work to ensure that agreed objectives, timescales and budgets are met.

As a Device Quality Engineer, you will have the following qualifications, skills and experience:
- Proven experience developing and/or supporting developed Medical Devices and/or Combination Products, preferably in a pharmaceutical environment
- In depth knowledge of GMP, GLP as well as quality management systems such as QSR, Medical Device Directives and relevant ISO standards.
- Demonstrated experience of working within device design control procedures and knowledge of associated tools such as risk analysis.
- Proven understanding of how a device has been designed and collaborate with/challenge relevant external partners such as design consultants & device manufacturers
- Experience of preparing regulatory documentation e.g. in eCTD format would be advantageous

Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.

CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.

If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference TC41519 in all correspondence.

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