Hilo by Aktiia
Automation Manager(m/w/x)
Vollzeitmit HomeofficeSenior
Neuenburg
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
HIHilo by Aktiia
Sr. Quality Engineer - Manufacturing(m/w/x)
Neuenburg
Vollzeitmit HomeofficeSenior
Nejo KI-Zusammenfassung
Quality engineering for continuous blood pressure monitor manufacturing with contract partners. ISO and FDA QSR knowledge required. Flexible work location, hybrid schedule, occasional international travel.
Anforderungen
- Bachelor's degree in technical or scientific field
- 5-8 years experience in quality or manufacturing
- Team leadership skills
- Independent project prioritization, execution, and reporting
- Knowledge of ISO and FDA/Quality System Requirements
- Strong project management skills
- Strong time management skills
- Familiarity with Risk Management per ISO 14971
- Creative problem solving for complex issues
- Effective problem solving for complex issues
- Ability to work on multiple tasks concurrently
- Ability to manage changing priorities
- Proficiency with MS Teams
- Proficiency with MS Word
- Proficiency with MS Excel
- Proficiency with MS PowerPoint
- Proficiency with AI tools
- Proficiency with eQMS systems
- Bachelor's Degree
- Mid-Senior level experience
Aufgaben
- Lead quality engineering activities with contract manufacturers
- Support IQ, OQ, PQ processes and non-conformance resolution
- Conduct process and test method validations
- Resolve manufacturing non-conformances with contract manufacturers
- Approve DHRs, DHF deliverables, product releases, and change orders
- Coach manufacturing personnel and contract manufacturers on GMP and QMS
- Lead cross-functional teams to resolve quality issues
- Navigate the CAPA process
- Drive product improvement and operational efficiency projects
- Support internal labeling reviews for required markings and symbols
- Lead supplier management activities for contract manufacturers
- Conduct supplier audits, qualifications, and assessments
- Support QMS audits with internal and external auditors
Berufserfahrung
- 5 - 8 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- MS Teams
- MS Word
- MS Excel
- MS PowerPoint
- AI tools
- eQMS systems
- ISO 13485
- ISO 14971
- FDA 21 CFR Part 820
- MDR
- FMEA
Benefits
Flexibles Arbeiten
- Flexible work location
- Hybrid work schedule
Sonstige Vorteile
- Occasional international travel
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Hilo by Aktiia erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
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HIHilo by Aktiia
Sr. Quality Engineer - Manufacturing(m/w/x)
Neuenburg
Vollzeitmit HomeofficeSenior
Nejo KI-Zusammenfassung
Quality engineering for continuous blood pressure monitor manufacturing with contract partners. ISO and FDA QSR knowledge required. Flexible work location, hybrid schedule, occasional international travel.
Anforderungen
- Bachelor's degree in technical or scientific field
- 5-8 years experience in quality or manufacturing
- Team leadership skills
- Independent project prioritization, execution, and reporting
- Knowledge of ISO and FDA/Quality System Requirements
- Strong project management skills
- Strong time management skills
- Familiarity with Risk Management per ISO 14971
- Creative problem solving for complex issues
- Effective problem solving for complex issues
- Ability to work on multiple tasks concurrently
- Ability to manage changing priorities
- Proficiency with MS Teams
- Proficiency with MS Word
- Proficiency with MS Excel
- Proficiency with MS PowerPoint
- Proficiency with AI tools
- Proficiency with eQMS systems
- Bachelor's Degree
- Mid-Senior level experience
Aufgaben
- Lead quality engineering activities with contract manufacturers
- Support IQ, OQ, PQ processes and non-conformance resolution
- Conduct process and test method validations
- Resolve manufacturing non-conformances with contract manufacturers
- Approve DHRs, DHF deliverables, product releases, and change orders
- Coach manufacturing personnel and contract manufacturers on GMP and QMS
- Lead cross-functional teams to resolve quality issues
- Navigate the CAPA process
- Drive product improvement and operational efficiency projects
- Support internal labeling reviews for required markings and symbols
- Lead supplier management activities for contract manufacturers
- Conduct supplier audits, qualifications, and assessments
- Support QMS audits with internal and external auditors
Berufserfahrung
- 5 - 8 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- MS Teams
- MS Word
- MS Excel
- MS PowerPoint
- AI tools
- eQMS systems
- ISO 13485
- ISO 14971
- FDA 21 CFR Part 820
- MDR
- FMEA
Benefits
Flexibles Arbeiten
- Flexible work location
- Hybrid work schedule
Sonstige Vorteile
- Occasional international travel
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Hilo by Aktiia erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Über das Unternehmen
Hilo by Aktiia
Branche
Healthcare
Beschreibung
Hilo by Aktiia develops technology to help people control their blood pressure, aiming for a world where no lives are lost or damaged from its effects. Their cuffless blood pressure monitor is medically accurate and CE Marked.
Noch nicht perfekt?
- Hilo by Aktiia
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Vollzeitmit HomeofficeSeniorBoudry - Hilo by Aktiia
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