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Quality Engineer - Operations Quality(m/w/x)
Reducing defect rates for MedTech products through new quality standards and check methods. Problem-solving expertise with CAPA, 8D, 5-Why, Ishikawa, or A3 required. Comprehensive Total Rewards program, performance-based culture.
Requirements
- Bachelor's degree or equivalent in technical field
- Minimum 3 years experience in regulated environment (ISO 9001, IATF 16949, ISO 13485)
- Experience with problem-solving methods (CAPA, 8D, 5-Why, Ishikawa, A3)
- Fluent German and English (written and verbal)
- Proficient knowledge of Microsoft Office software
- Growth mindset
- Passion to drive change in dynamic, rapidly growing business
- Strong influencing and interpersonal communication skills (effective and assertive)
Tasks
- Improve BD Rowa product quality by reducing defect rates
- Develop and implement quality standards for products and services
- Focus employees on quality improvement
- Develop and improve methods for quality checks
- Analyze and reduce non-conformances and failures
- Conduct systematic root cause analysis and Gemba Walks
- Report quality trends, performance, and countermeasures
- Develop and apply process validation
- Perform capability studies of testing equipment
- Maintain and develop quality documentation
- Review processes regularly
- Handle customer, internal, and supplier complaints
- Conduct root cause analysis for complaints
- Implement corrective and preventive actions
- Develop and improve internal procedures and applications
- Manage and coordinate external calibration activities
- Interface with service providers for calibration
- Ensure compliance with quality and regulatory requirements
- Conduct on-site quality activities at supplier premises
- Verify process performance at supplier sites
- Support root cause analysis at supplier sites
- Ensure compliance with BD Rowa quality and regulatory requirements
- Support process improvement initiatives
- Develop and establish local processes
- Own and support Corrective Action and Preventive Action (CAPA) projects
- Implement CAPA action items
- Perform continuous improvement techniques
- Use Lean, Six-Sigma, Poka-Yoke, Measurement System Analysis, and FMEA
- Support internal and external audits
Work Experience
- 3 years
Education
- Bachelor's degree
Languages
- German – Business Fluent
- English – Business Fluent
Tools & Technologies
- Microsoft Office
Benefits
Other Benefits
- Comprehensive Total Rewards program
- Performance-based culture
Competitive Pay
- Competitive package of compensation and benefits
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Quality Engineer - Operations Quality(m/w/x)
Reducing defect rates for MedTech products through new quality standards and check methods. Problem-solving expertise with CAPA, 8D, 5-Why, Ishikawa, or A3 required. Comprehensive Total Rewards program, performance-based culture.
Requirements
- Bachelor's degree or equivalent in technical field
- Minimum 3 years experience in regulated environment (ISO 9001, IATF 16949, ISO 13485)
- Experience with problem-solving methods (CAPA, 8D, 5-Why, Ishikawa, A3)
- Fluent German and English (written and verbal)
- Proficient knowledge of Microsoft Office software
- Growth mindset
- Passion to drive change in dynamic, rapidly growing business
- Strong influencing and interpersonal communication skills (effective and assertive)
Tasks
- Improve BD Rowa product quality by reducing defect rates
- Develop and implement quality standards for products and services
- Focus employees on quality improvement
- Develop and improve methods for quality checks
- Analyze and reduce non-conformances and failures
- Conduct systematic root cause analysis and Gemba Walks
- Report quality trends, performance, and countermeasures
- Develop and apply process validation
- Perform capability studies of testing equipment
- Maintain and develop quality documentation
- Review processes regularly
- Handle customer, internal, and supplier complaints
- Conduct root cause analysis for complaints
- Implement corrective and preventive actions
- Develop and improve internal procedures and applications
- Manage and coordinate external calibration activities
- Interface with service providers for calibration
- Ensure compliance with quality and regulatory requirements
- Conduct on-site quality activities at supplier premises
- Verify process performance at supplier sites
- Support root cause analysis at supplier sites
- Ensure compliance with BD Rowa quality and regulatory requirements
- Support process improvement initiatives
- Develop and establish local processes
- Own and support Corrective Action and Preventive Action (CAPA) projects
- Implement CAPA action items
- Perform continuous improvement techniques
- Use Lean, Six-Sigma, Poka-Yoke, Measurement System Analysis, and FMEA
- Support internal and external audits
Work Experience
- 3 years
Education
- Bachelor's degree
Languages
- German – Business Fluent
- English – Business Fluent
Tools & Technologies
- Microsoft Office
Benefits
Other Benefits
- Comprehensive Total Rewards program
- Performance-based culture
Competitive Pay
- Competitive package of compensation and benefits
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
BD Rowa Germany GmbH
Industry
Healthcare
Description
Das Unternehmen ist eines der größten globalen Medizintechnologie-Unternehmen, das sich für ein nachhaltig robustes Gesundheitswesen engagiert.
Not a perfect match?
- Becton, Dickinson and Company
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Full-timeOn-siteExperiencedKelbergfrom 58,500 - 89,250 / year - BD Rowa Germany GmbH
Quality Engineer, Software(m/w/x)
Full-timeOn-siteExperiencedKelbergfrom 87,375 / year - 0727 BD Rowa Germany GmbH
Procurement Manager(m/w/x)
Full-time/Part-timeOn-siteExperiencedKelbergfrom 126,700 / year - BD Rowa Germany GmbH
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Full-time/Part-timeOn-siteExperiencedKelberg - BD Rowa Germany GmbH
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