Zühlke Engineering AG
Senior QA Consultant(m/w/x)
Full-timeWith HomeofficeSenior
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NDndd Medizintechnik AG
Quality & Regulatory Affairs Manager(m/w/x)
Zürich
Full-timeWith Home OfficeSenior
Nejo AI Summary
Improving lung function testing accessibility with QMS and regulatory compliance. 5+ years medical device QA/RA experience required. Flexible hours, hybrid work, modern tech.
Requirements
- Bachelor's or Master's degree in biomedical engineering, life science, or comparable technical/scientific field
- At least 5 years of professional experience in quality management, quality assurance, and regulatory affairs within the medical device industry
- Proven experience with QMS, audits, supplier management, and product development projects
- Solid knowledge of medical device regulations and applicable standards
- Strong understanding of Quality Management Systems, risk management, and product lifecycle processes
- Structured, analytical, and quality-focused working style
- Ability to work independently and cross-functionally
- Strong communication skills and confidence in interaction with stakeholders
- Leadership and decision-making capabilities
- Leadership experience in quality functions is an advantage
- Strong knowledge of ISO 13485, QMSR, ISO 14971, IEC 60601-1
- Excellent knowledge of documentation and quality tools
- Professional fluency in English
- Professional fluency in German
- Additional languages are a plus
Tasks
- Maintain and improve Quality Management System
- Ensure compliance with regulatory requirements
- Maintain effective document control and record keeping
- Prepare and update quality reports
- Support internal and external audits
- Follow up on audit findings
- Ensure regulatory compliance in all markets
- Support product registrations and changes
- Monitor regulatory changes and assess impacts
- Coordinate third-party testing activities
- Lead supplier quality activities
- Monitor supplier performance
- Manage supplier nonconformities
- Support customer quality issues
- Investigate and resolve customer complaints
- Evaluate customer feedback
- Manage CAPA activities
- Conduct root cause analysis
- Implement and verify CAPA effectiveness
- Support Engineering Change Orders
- Ensure quality and regulatory compliance in ECOs
- Maintain documentation integrity
- Support Post Market Surveillance
- Collect and evaluate PMS data
- Support risk management activities
- Ensure PMS and risk outputs are reflected in CAPA
- Update product labelling and documentation
Work Experience
- 5 - 7 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
- German – Business Fluent
Tools & Technologies
- MS Office
- Polarion
- Salesforce
- ISO 13485
- QMSR
- ISO 14971
- IEC 60601-1
Benefits
Flexible Working
- Flexible working hours
- Hybrid work
Other Benefits
- Comprehensive onboarding
- Equal opportunities
- Diversity
- Inclusion
Modern Equipment
- Professional and modern technology
Informal Culture
- Collegial and supportive working environment
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of ndd Medizintechnik AG 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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NDndd Medizintechnik AG
Quality & Regulatory Affairs Manager(m/w/x)
Zürich
Full-timeWith Home OfficeSenior
Nejo AI Summary
Improving lung function testing accessibility with QMS and regulatory compliance. 5+ years medical device QA/RA experience required. Flexible hours, hybrid work, modern tech.
Requirements
- Bachelor's or Master's degree in biomedical engineering, life science, or comparable technical/scientific field
- At least 5 years of professional experience in quality management, quality assurance, and regulatory affairs within the medical device industry
- Proven experience with QMS, audits, supplier management, and product development projects
- Solid knowledge of medical device regulations and applicable standards
- Strong understanding of Quality Management Systems, risk management, and product lifecycle processes
- Structured, analytical, and quality-focused working style
- Ability to work independently and cross-functionally
- Strong communication skills and confidence in interaction with stakeholders
- Leadership and decision-making capabilities
- Leadership experience in quality functions is an advantage
- Strong knowledge of ISO 13485, QMSR, ISO 14971, IEC 60601-1
- Excellent knowledge of documentation and quality tools
- Professional fluency in English
- Professional fluency in German
- Additional languages are a plus
Tasks
- Maintain and improve Quality Management System
- Ensure compliance with regulatory requirements
- Maintain effective document control and record keeping
- Prepare and update quality reports
- Support internal and external audits
- Follow up on audit findings
- Ensure regulatory compliance in all markets
- Support product registrations and changes
- Monitor regulatory changes and assess impacts
- Coordinate third-party testing activities
- Lead supplier quality activities
- Monitor supplier performance
- Manage supplier nonconformities
- Support customer quality issues
- Investigate and resolve customer complaints
- Evaluate customer feedback
- Manage CAPA activities
- Conduct root cause analysis
- Implement and verify CAPA effectiveness
- Support Engineering Change Orders
- Ensure quality and regulatory compliance in ECOs
- Maintain documentation integrity
- Support Post Market Surveillance
- Collect and evaluate PMS data
- Support risk management activities
- Ensure PMS and risk outputs are reflected in CAPA
- Update product labelling and documentation
Work Experience
- 5 - 7 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
- German – Business Fluent
Tools & Technologies
- MS Office
- Polarion
- Salesforce
- ISO 13485
- QMSR
- ISO 14971
- IEC 60601-1
Benefits
Flexible Working
- Flexible working hours
- Hybrid work
Other Benefits
- Comprehensive onboarding
- Equal opportunities
- Diversity
- Inclusion
Modern Equipment
- Professional and modern technology
Informal Culture
- Collegial and supportive working environment
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of ndd Medizintechnik AG 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.
About the Company
ndd Medizintechnik AG
Industry
Healthcare
Description
ndd Medizintechnik AG is a leading innovator in pulmonary function testing devices, improving early detection of chronic lung diseases with spirometry devices sold in over 100 countries.
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