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New Product Introduction Quality Engineer(m/w/x)
Defining quality requirements for new MedTech products, incorporating them into designs and processes. Medical device quality engineering experience with regulatory knowledge required. Comprehensive Total Rewards program, performance-based culture.
Requirements
- Bachelor's degree in Engineering or related technical field
- Quality Engineering experience in medical device industry
- In-depth knowledge of medical device regulations and standards
- Proven experience with design controls, risk management, design verification, and process validation
- Strong understanding of statistical process control and QA methodologies
- Excellent problem-solving and root cause analysis skills
- Proficiency in technical report writing and documentation
- Strong communication and interpersonal skills
- ASQ CQE or Six Sigma Green/Black Belt certifications (plus)
- Fluency in English (written and spoken)
Tasks
- Collaborate with R&D, Manufacturing, and Regulatory teams
- Define quality requirements for new products
- Incorporate quality requirements into product designs and processes
- Develop and implement quality plans
- Create design verification and validation strategies
- Conduct risk assessments (e.g., FMEA)
- Support risk mitigation strategies
- Participate in design reviews
- Provide expert quality input
- Ensure adherence to design control procedures
- Ensure compliance with medical device regulations
- Develop product specifications
- Review and approve test protocols
- Review and approve inspection plans
- Oversee Gage R&R studies
- Perform process capability analyses
- Support supplier and component qualification
- Ensure supplier and component quality standards
- Investigate quality issues
- Resolve quality issues during development
- Resolve quality issues during testing
- Resolve quality issues during early production
- Ensure smooth product transfer to manufacturing
- Establish quality control points
- Maintain NPI quality documentation
- Contribute to continuous improvement initiatives
Work Experience
- approx. 1 - 4 years
Education
- Bachelor's degree
Languages
- English – Fluent
Benefits
Other Benefits
- Comprehensive Total Rewards program
- Performance-based culture
- Competitive benefits package
Competitive Pay
- Competitive compensation package
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New Product Introduction Quality Engineer(m/w/x)
Defining quality requirements for new MedTech products, incorporating them into designs and processes. Medical device quality engineering experience with regulatory knowledge required. Comprehensive Total Rewards program, performance-based culture.
Requirements
- Bachelor's degree in Engineering or related technical field
- Quality Engineering experience in medical device industry
- In-depth knowledge of medical device regulations and standards
- Proven experience with design controls, risk management, design verification, and process validation
- Strong understanding of statistical process control and QA methodologies
- Excellent problem-solving and root cause analysis skills
- Proficiency in technical report writing and documentation
- Strong communication and interpersonal skills
- ASQ CQE or Six Sigma Green/Black Belt certifications (plus)
- Fluency in English (written and spoken)
Tasks
- Collaborate with R&D, Manufacturing, and Regulatory teams
- Define quality requirements for new products
- Incorporate quality requirements into product designs and processes
- Develop and implement quality plans
- Create design verification and validation strategies
- Conduct risk assessments (e.g., FMEA)
- Support risk mitigation strategies
- Participate in design reviews
- Provide expert quality input
- Ensure adherence to design control procedures
- Ensure compliance with medical device regulations
- Develop product specifications
- Review and approve test protocols
- Review and approve inspection plans
- Oversee Gage R&R studies
- Perform process capability analyses
- Support supplier and component qualification
- Ensure supplier and component quality standards
- Investigate quality issues
- Resolve quality issues during development
- Resolve quality issues during testing
- Resolve quality issues during early production
- Ensure smooth product transfer to manufacturing
- Establish quality control points
- Maintain NPI quality documentation
- Contribute to continuous improvement initiatives
Work Experience
- approx. 1 - 4 years
Education
- Bachelor's degree
Languages
- English – Fluent
Benefits
Other Benefits
- Comprehensive Total Rewards program
- Performance-based culture
- Competitive benefits package
Competitive Pay
- Competitive compensation package
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
Straub Medical AG
Industry
Healthcare
Description
Das Unternehmen entwickelt, produziert und vermarktet Hightech-Medizingeräte zur Behandlung von Durchblutungsstörungen.
Not a perfect match?
- Becton, Dickinson and Company
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Mitarbeiter Qualitätssicherung(m/w/x)
Full-timeOn-siteEntry LevelVilters-Wangsfrom CHF 60,000 - 91,500 / year - 223 TCH - TRUMPF Schweiz AG
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