Senior Quality Engineer

Renishaw; Chassieu; Sur place; EUR 40 000 - 70 000; Plein temps

Résumé du poste

Une entreprise innovante dans le secteur des dispositifs médicaux recherche un Ingénieur Qualité Senior pour rejoindre son équipe dynamique à Chassieu. Dans ce rôle, vous serez responsable de la mise en œuvre et du contrôle du système de gestion de la qualité, tout en collaborant avec des équipes internationales. Vous aurez l'opportunité de travailler sur des produits de pointe, y compris des robots utilisés en neurochirurgie. Ce poste offre une chance unique de contribuer à des projets significatifs tout en évoluant dans un environnement collaboratif et inclusif, favorisant le développement professionnel à long terme.

Prestations

Ordinateur portable

Téléphone mobile

Bonus annuel discrétionnaire

Initiatives de formation personnalisées

Opportunités de développement professionnel

Programme de parrainage avec compensation

Avantages en matière de bien-être en ligne

Culture collaborative et inclusive

Qualifications

• 4-6 ans d'expérience en ingénierie qualité dans le secteur des dispositifs médicaux.
• Connaissance approfondie des normes ISO et des réglementations qualité.

Responsabilités

• Mettre en œuvre et contrôler le système de gestion de la qualité.
• Préparer et organiser des audits internes et des audits fournisseurs.

Connaissances

Analyse des causes profondes

Gestion des produits non conformes

CAPA

Connaissance des outils qualité

Compétences en communication

Bilingue français et anglais

Formation

Diplôme en sciences de la vie ou en ingénierie

Expérience pertinente

Outils

ISO 13485

ISO 14971

21CFR Part 820

MDSAP

Description du poste

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