Overview

Job Description

A vacancy has arisen for an experienced Medical Quality Engineer.

The successful candidate will be required to provide Quality Engineering support for manufactured or subcontract manufactured current and development products, these include a drug delivery system (neuroinfuse), surgical planning software (neuroinspire) and devices supporting neurosurgery.

Key tasks will include the review and/or generation of non-conformance reports, CAPA, audit, validation protocols/reports, risk management and design change documentation.

The successful candidate will be required to work closely with the development and manufacturing teams based in Gloucestershire and Swords (Ireland). Therefore, some travel is a requirement of the role.

Responsibilities

  • Provide Quality Engineering support for activities including nonconformities, CAPA, validation and risk management activities

  • Deputise for the Quality Manager as and when required

  • Support product design change activities

  • Validation support

Key requirements

  • Detailed knowledge of ISO13485, ISO 14971 and 21CFR Part 820 Quality System Regulation (QSR)

  • 4-6 years’ experience in a medical device Quality Engineering role

  • Experience in nonconforming product management, CAPA, design change activities and validation activities

  • Excellent communication skills

Desirable requirements

  • Life science, engineering, medically related degree or appropriate experience.

  • Knowledge of Quality tools and statistics

  • Experience in neurological or drug delivery devices

  • Additional validation experience (process, equipment, cleaning, sterilisation, Test Method Validation)

  • NPI

  • Knowledge of injection and extrusion moulding processes

  • Lead auditor trained

  • 6 sigma green belt or above

Benefits 

When you join Renishaw, we're committing to your future career. That's because we believe in developing our people's skills and promoting them internally. We also offer a benefits package that's highly desirable; including a 9% non-contributory pension, discretionary annual bonus, *subsidised onsite restaurants and *coffee shops, free parking, *car sharing scheme and *24 hour fitness centres. (*not available at our Castle Donington, Exeter, York & Edinburgh sites).

We also want to promote a healthy work-life balance as much as possible, so we have introduced a hybrid working policy which allows for a combination of home and office based working depending on the nature of your role. We also offer a variable working programme, 25 days holiday plus bank holidays, Life Assurance policy of 12 times annual salary, Cycle to Work scheme, enhanced maternity pay subject to qualifying criteria, the option to join BUPA Renishaw health trust and an Employee Assistance Programme for employees and family.

Please click here for further information about our benefits.

At Renishaw we believe that our success is powered by welcoming a workforce of diverse and talented people. Through encouraging an inclusive culture, where all our employees are free to be themselves, we can achieve our core values: Innovation, Inspiration, Integrity, and Involvement.
 
If you are excited about the role but feel as though you don’t meet all the requirements, we would encourage you still to apply. You might just be the right person for this role or another opportunity at Renishaw.
 
We are committed to providing reasonable adjustments to make interviews and jobs more accessible. Should you have any difficulty during the recruitment process, or require any reasonable adjustments please contact the recruitment team on 01453 524600 or recruitment@renishaw.com.

Please click here for further information about diversity and inclusion at Renishaw.

Employment Type:

Permanent

Time Type:

Full time

Requisition Number:

R6481 Medical Quality Engineer (Open)

Location:

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