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Senior Design Quality

Quality
Ref: 200 Date Posted: Monday 16 Jul 2018
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Senior Design Quality Engineer

Salary: Competitive salary on offer

Benefits: Comprehensive benefits on offer

Location: Hull

Or client is a diversified advanced medical technology business that supports healthcare professionals in more than 100 countries to improve the quality of life for their patients. They have leadership positions in Orthopedics Reconstruction (joint replacement systems for knees, hips and shoulders); Advanced Wound Management (wound care treatment and prevention products used to treat hard to heal wounds); Sports Medicine and Trauma.

 

Summary

We have an exciting opportunity for a Senior Design Quality Engineer working with a wide variety of departments and teams. You will play a pivotal role in Design Control and Change Control projects, having overall responsibility for assuring that products are designed and maintained in a manner compliant with all applicable global Quality System Regulations. This includes the creation and maintenance of design history files and risk management files for the company’s medical devices throughout the product lifecycle. 

 

Essential Job Functions

  • Provision of quality leadership to new product development and sustaining project teams as the quality engineering representative.  Work with the team to develop methods and procedures to ensure that the appropriate tests are conducted to meet the required design.
  • Generate, approve and/or manage design verification and validation activities.
  • Actively participate in and/or facilitate the development, review and approval of  requirements  and deliverables to support medical device product software development.
  • Provide support to Operations teams to ensure successful transfer of the design and design controls to manufacturing.
  • Support continuous improvement activities including CAPA
  • Support Post market surveillance activities, Management review, Audits and inspections.
  • To perform all activities in compliance with relevant GMP, the company’s Quality Systems and safety standards and with FDA Quality System Regulation and ISO 13485. 

 

Requirements

  • Holds a professional / academic scientific qualification e.g. B.Sc. Hons Engineering/ Electrical/Electronic/ Mechanical, Biomedical Science/ Biochemistry/ Chemistry.
  • Experience in a similar Product Development Engineering role or Quality/ Compliance/ Regulatory related role in relation to product development within a Medical Devices or other highly regulated industry.
  • Knowledge of Medical Device Quality Systems standards and specifically Design Control according to 21CFR820 and ISO 13485, and Risk Management for medical devices in accordance with ISO14971 preferred.
  • Knowledge of and use a variety of software risk management tools, design and process control activities, usability and validation testing methodologies to support software product quality for new and existing product development, in accordance with IEC 62304.

Specialists in consultancy


At Medical Engineers we have a range of technical consulting jobs in the medical engineering industry throughout the UK. Requiring a broad range of technical and management skills and most importantly the ability to communicate effectively. Consultancy roles require candidates with unique abilities. Roles vary in length of contract depending on clients’ requirements.

Our degree qualified consultants have specialist knowledge of the UK medical engineering consultancy job market. We have a successful track record in finding the best candidates for our clients who know and trust Medical Engineers to understand their business requirements.

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