Dein persönlicher KI-Karriere-Agent
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.
Anforderungen
- 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)
Aufgaben
- 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
Berufserfahrung
- ca. 1 - 4 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – fließend
Benefits
Sonstige Vorteile
- Comprehensive Total Rewards program
- Performance-based culture
- Competitive benefits package
Attraktive Vergütung
- Competitive compensation package
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
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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.
Anforderungen
- 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)
Aufgaben
- 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
Berufserfahrung
- ca. 1 - 4 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – fließend
Benefits
Sonstige Vorteile
- Comprehensive Total Rewards program
- Performance-based culture
- Competitive benefits package
Attraktive Vergütung
- Competitive compensation package
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
Über das Unternehmen
Straub Medical AG
Branche
Healthcare
Beschreibung
Das Unternehmen entwickelt, produziert und vermarktet Hightech-Medizingeräte zur Behandlung von Durchblutungsstörungen.
Noch nicht perfekt?
- Becton, Dickinson and Company
Quality Engineer – Medical Devices(m/w/x)
Vollzeitnur vor OrtBerufserfahrenVilters-Wangsab CHF 145.775 / Jahr - Becton, Dickinson and Company
Manufacturing Engineer(m/w/x)
Vollzeitnur vor OrtBerufserfahrenVilters-Wangsab CHF 145.775 / Jahr - BD
Mitarbeiter Qualitätssicherung(m/w/x)
Vollzeitnur vor OrtBerufseinsteigerVilters-Wangsab CHF 60.000 - 91.500 / Jahr - 223 TCH - TRUMPF Schweiz AG
Supplier Quality Manager (SQM) im strategischen Einkauf(m/w/x)
Vollzeitnur vor OrtSeniorGrüsch - Hamilton Bonaduz AG
Product Manager - Biopharma Process Analytics(m/w/x)
Vollzeitnur vor OrtBerufserfahrenEms