Job Description

Mission

A vacancy has arisen for an experienced Senior Quality Engineer working within Renishaw Mayfield based in Chassieu, in Lyon region.

The successful candidate will be required to provide Quality Engineering support for Mayfield manufactured or subcontract manufactured current and development products, these include a robot used in neurosurgery and supporting devices.

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 team in Lyon, as well as across teams based in Gloucestershire (England) and Swords (Ireland).

The candidate will be required to be on-site a minimum of 3 days a week.

Main Responsibilities

• With the support of the QM, implement, maintain and control the Quality Management System and maintain its effectiveness
• Prepare, organize and carry out internal and supplier audits
• Support notified body audits, and lead on follow-up tasks from the audits
• Line management of the Quality Technician
• Review and approve CAPAs, non-conformances and complaints
• Participate in projects as the quality representative, reviewing and approving associated documents
• Provide training to staff on the procedures and instructions put in place
• Prepare, organize and lead management reviews
• Monitor Quality indicators related to the company's processes
• Participate in post-market surveillance activities
• Review DHR, inspection/build paperwork and release product
• Daily support to operational teams especially for the handling of non-conforming products
• Define and implement quality process improvements
• Fostering the team's quality mindset

Requirements

Key Requirements:

• 4-6 years' experience in a medical device Quality Engineering role
• Detailed knowledge of ISO13485, ISO 14971 and 21CFR Part 820 Quality System Regulation (QSR) and MDSAP
• Experience in nonconforming product management, CAPA, design change activities, risk and validation activities
• Strong root cause analysis skills
• Ability to write documents and speak fluently in French and English.
• Travel to subsidiary sites and suppliers will be a requirement of the position.

Desirable requirements:

• Life science, engineering, medically related degree or appropriate experience
• Experience in neurological devices
• Knowledge of Quality tools and statistics
• Additional validation experience (process, equipment, cleaning, sterilisation, Test Method Validation)
• Lead auditor trained for ISO 13485 / Internal auditor trained to ISO 13495 / MDSAP
• NPI
• 6 sigma green belt or above
• Experience in line managing

Person specification

• The successful applicant will be organised and self-motivated, possessing an eye for detail and excellent communication skills.
• Embracing change is essential, as it allows the applicant to adapt and thrive in a dynamic environment.
• As a team player, the applicant will be self-determined and have a strong voice for Quality, ensuring high standards are maintained.
• Working to strict deadlines is crucial, and the applicant will encourage and facilitate others to do the same.
• Finally, the ability to cope with pressured situations and to be flexible in working hours is an essential requirement of this role, ensuring the applicant can handle the demands of the position effectively.

What we offer

• Location: Chassieu, Lyon region
• Salary: in accordance with experience and qualifications
• Permanent and full-time contract
• Laptop, mobile phone
• Immediate incorporation

and additional benefits, such as:

• Discretionary annual bonus
• Training customized initiatives
• Long-term opportunities for professional development in an international company
• Referral program with paid compensation
• Online wellbeing benefits
• A collaborative and inclusive culture of sharing and teamwork

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. We believe in a culture of diversity to attract the best people, be part of the best environments and adapt to our diverse customers. We provide equal consideration for employment to all qualified applicants without regards to race, colour, religion, sex, gender identity, sexual orientation, experience, background, age, perspectives and abilities. Renishaw is an equal opportunity employer and is committed to provide any reasonable accommodation for differently abled candidates. Should you have any difficulty during the recruitment process, or require any reasonable adjustments please contact the recruitment team at hr.emea@renishaw.com. Please click here for further information about diversity and inclusion at Renishaw.

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