HITACHI ENERGY LTD
Internship in Process Engineering (warranty)(m/w/x)
Full-timeInternshipOn-site
Genf
New Job?Nejo!
Your personal AI career agent
INinnovative specialist spinal implant company
Process Validation Engineer - Cleanroom(m/w/x)
Plan-les-Ouates
Full-timeOn-siteExperienced
Nejo AI Summary
Cleanroom validation for spinal implants, managing IQ/OQ/PQ and environmental monitoring. Medical device validation experience required. Collaboration across R&D, Operations, and RA departments.
Requirements
- Proven experience in Validation and Qualification processes
- Experience in medical devices or pharmaceutical industry
- Demonstrated use of ISO 13485, ISO 14971, 21 CFR Part 820, EU MDR 2017/745
- Experience in orthopaedic and/or spinal medical device development
- Higher qualification / degree as Quality Engineer
- Effective work in English
- Native or near-native level of French
- Strong communication skills
- Ability to clearly convey technical information
- Ability to explain complex regulatory requirements simply
- Excellent technical writing skills
- Structured documentation (protocols, reports, audit-ready records)
- Ability to manage multiple projects and validation activities
- Ability to manage under tight deadlines
- Ability to challenge decisions impacting patient safety or regulatory compliance
- Strong problem-solving skills
- Pragmatic and solution-oriented approach
- Valid driving licence
Tasks
- Participate in qualification-validation strategy
- Collaborate with R&D, Operations, and RA departments
- Manage cleanroom qualification activities
- Monitor environmental monitoring, requalification, and contamination control
- Coordinate validation activities (IQ/OQ/PQ) for equipment and systems
- Lead investigations and root cause analysis
- Resolve non-conformities and implement CAPA
- Ensure compliance with ISO 13485, ISO 14971, 21 CFR Part 820, EU MDR 2017/745
- Analyze quality metrics
- Identify opportunities for continuous improvement
- Create, review, and approve quality documentation
- Interact with auditors
- Collaborate with Production, Engineering, Regulatory Affairs, and suppliers
- Participate in DHF completeness
- Define and plan validation/verification activities
- Execute and review validation/verification activities
- Manage changes and assess impact
Work Experience
- 3 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
- French – Native
Tools & Technologies
- ISO 13485
- ISO 14971
- 21 CFR Part 820
- EU MDR 2017/745
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of innovative specialist spinal implant company and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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INinnovative specialist spinal implant company
Process Validation Engineer - Cleanroom(m/w/x)
Plan-les-Ouates
Full-timeOn-siteExperienced
Nejo AI Summary
Cleanroom validation for spinal implants, managing IQ/OQ/PQ and environmental monitoring. Medical device validation experience required. Collaboration across R&D, Operations, and RA departments.
Requirements
- Proven experience in Validation and Qualification processes
- Experience in medical devices or pharmaceutical industry
- Demonstrated use of ISO 13485, ISO 14971, 21 CFR Part 820, EU MDR 2017/745
- Experience in orthopaedic and/or spinal medical device development
- Higher qualification / degree as Quality Engineer
- Effective work in English
- Native or near-native level of French
- Strong communication skills
- Ability to clearly convey technical information
- Ability to explain complex regulatory requirements simply
- Excellent technical writing skills
- Structured documentation (protocols, reports, audit-ready records)
- Ability to manage multiple projects and validation activities
- Ability to manage under tight deadlines
- Ability to challenge decisions impacting patient safety or regulatory compliance
- Strong problem-solving skills
- Pragmatic and solution-oriented approach
- Valid driving licence
Tasks
- Participate in qualification-validation strategy
- Collaborate with R&D, Operations, and RA departments
- Manage cleanroom qualification activities
- Monitor environmental monitoring, requalification, and contamination control
- Coordinate validation activities (IQ/OQ/PQ) for equipment and systems
- Lead investigations and root cause analysis
- Resolve non-conformities and implement CAPA
- Ensure compliance with ISO 13485, ISO 14971, 21 CFR Part 820, EU MDR 2017/745
- Analyze quality metrics
- Identify opportunities for continuous improvement
- Create, review, and approve quality documentation
- Interact with auditors
- Collaborate with Production, Engineering, Regulatory Affairs, and suppliers
- Participate in DHF completeness
- Define and plan validation/verification activities
- Execute and review validation/verification activities
- Manage changes and assess impact
Work Experience
- 3 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
- French – Native
Tools & Technologies
- ISO 13485
- ISO 14971
- 21 CFR Part 820
- EU MDR 2017/745
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of innovative specialist spinal implant company and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
innovative specialist spinal implant company
Industry
Healthcare
Description
The company is an innovative specialist spinal implant company committed to ethical practices and patient trust.
Not a perfect match?
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