Dein persönlicher KI-Karriere-Agent
Quality Engineer I(m/w/x)
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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- ca. 1 - 4 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – fließend
- Französisch – fließend
Tools & Technologien
- Agile
- Oracle
- EtQ
- Trackwise
- ICDH
- Minitab
- Microsoft office tools
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- Home
- Jobs in der Schweiz
- Le Locle
- Quality Engineer IQuality Engineer I bei Integra LifeSciences Switzerland Sàrl
Quality Engineer I(m/w/x)
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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- ca. 1 - 4 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – fließend
- Französisch – fließend
Tools & Technologien
- Agile
- Oracle
- EtQ
- Trackwise
- ICDH
- Minitab
- Microsoft office tools
Über das Unternehmen
Integra LifeSciences Switzerland Sàrl
Branche
Healthcare
Beschreibung
The company is dedicated to improving healthcare outcomes through innovative solutions.
Noch nicht perfekt?
- Bristol Myers Squibb
C&Q Engineer(m/w/x)
Vollzeitnur vor OrtJuniorBoudry - CHE - 8262 Baxalta Manufacturing Sarl
Quality Systems Specialist - Documentation(m/w/x)
Vollzeitnur vor OrtBerufserfahrenNeuenburg - INTEGRA LIFESCIENCES CORP
Quality Compliance Manager - ECMP Site Facilitator(m/w/x)
Vollzeitnur vor OrtSeniorLe Locle, Rietheim-Weilheim - Takeda
Product Quality Expert(m/w/x)
Vollzeitnur vor OrtBerufserfahrenNeuenburg - Integra LifeSciences Switzerland Sàrl
Staff Engineer, LSS Black Belt(m/w/x)
Vollzeitnur vor OrtSeniorLe Locle