Bristol Myers Squibb
C&Q Engineer(m/w/x)
Full-timeOn-siteJunior
Boudry
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INIntegra LifeSciences Switzerland Sàrl
Quality Engineer I(m/w/x)
Le Locle
Full-timeOn-siteExperienced
Nejo AI Summary
Maintaining compliant quality processes for medical devices, including nonconformance management and validation execution. Bachelor's degree in a technical field and medical device regulations knowledge required. Support for site quality activities, English and French communication skills.
Requirements
- Bachelor’s Degree in Engineering, Life Science, or related technical discipline
- Experience in Medical Device manufacturing environment
- Knowledge of Medical device standards and regulations (ISO13485, 93/42 EEC, 21 CFR part 820)
- Effective written and verbal communication skills in English and French
- Good communication, organizational, negotiation, and interpersonal skills
- Analytical problem-solving skills
- Use of Agile, Oracle, EtQ, Trackwise, ICDH, Minitab
- Use of Microsoft office tools
- Good knowledge of statistical techniques
- Fluent in French and English
Tasks
- Support site in maintaining strong, compliant quality processes
- Provide technical expertise for key quality activities
- Contribute to product and process quality control and improvement
- Manage nonconformance initiation, disposition, approval, and investigation
- Execute and document validation activities for new processes and products
- Write validation protocols and reports
- Complete and document risk analysis activities (PFMEA)
- Organize and prepare risk management documentation
- Ensure GMP rules are understood and applied
- Provide quality support to production teams and projects
- Offer guidance and training on quality requirements and best practices
- Support QC and laboratory departments technically
- Escalate quality issues and implement corrective actions
- Participate in internal and external audits and inspections
- Contribute to audit action closure
- Lead or participate in Quality-related projects
- Support complaint investigations
- Create, review, and revise quality procedures and documentation
- Manage, monitor, and document CAPAs
- Evaluate root causes and action effectiveness for CAPAs
- Support process improvement initiatives
Work Experience
- approx. 1 - 4 years
Education
- Bachelor's degree
Languages
- English – Fluent
- French – Fluent
Tools & Technologies
- Agile
- Oracle
- EtQ
- Trackwise
- ICDH
- Minitab
- Microsoft office tools
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Integra LifeSciences Switzerland Sàrl 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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INIntegra LifeSciences Switzerland Sàrl
Quality Engineer I(m/w/x)
Le Locle
Full-timeOn-siteExperienced
Nejo AI Summary
Maintaining compliant quality processes for medical devices, including nonconformance management and validation execution. Bachelor's degree in a technical field and medical device regulations knowledge required. Support for site quality activities, English and French communication skills.
Requirements
- Bachelor’s Degree in Engineering, Life Science, or related technical discipline
- Experience in Medical Device manufacturing environment
- Knowledge of Medical device standards and regulations (ISO13485, 93/42 EEC, 21 CFR part 820)
- Effective written and verbal communication skills in English and French
- Good communication, organizational, negotiation, and interpersonal skills
- Analytical problem-solving skills
- Use of Agile, Oracle, EtQ, Trackwise, ICDH, Minitab
- Use of Microsoft office tools
- Good knowledge of statistical techniques
- Fluent in French and English
Tasks
- Support site in maintaining strong, compliant quality processes
- Provide technical expertise for key quality activities
- Contribute to product and process quality control and improvement
- Manage nonconformance initiation, disposition, approval, and investigation
- Execute and document validation activities for new processes and products
- Write validation protocols and reports
- Complete and document risk analysis activities (PFMEA)
- Organize and prepare risk management documentation
- Ensure GMP rules are understood and applied
- Provide quality support to production teams and projects
- Offer guidance and training on quality requirements and best practices
- Support QC and laboratory departments technically
- Escalate quality issues and implement corrective actions
- Participate in internal and external audits and inspections
- Contribute to audit action closure
- Lead or participate in Quality-related projects
- Support complaint investigations
- Create, review, and revise quality procedures and documentation
- Manage, monitor, and document CAPAs
- Evaluate root causes and action effectiveness for CAPAs
- Support process improvement initiatives
Work Experience
- approx. 1 - 4 years
Education
- Bachelor's degree
Languages
- English – Fluent
- French – Fluent
Tools & Technologies
- Agile
- Oracle
- EtQ
- Trackwise
- ICDH
- Minitab
- Microsoft office tools
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Integra LifeSciences Switzerland Sàrl 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
Integra LifeSciences Switzerland Sàrl
Industry
Healthcare
Description
The company is dedicated to improving healthcare outcomes through innovative solutions.
Not a perfect match?
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