Jabil Switzerland Manufacturing GmbH
Senior Quality Engineer(m/w/x)
Vollzeitnur vor OrtSenior
Le Locle
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HIHilo by Aktiia
Senior Quality Engineer - Manufacturing(m/w/x)
VollzeitVor OrtSenior
AI/ML
Nejo KI-Zusammenfassung
Process validation (IQ, OQ, PQ) and test method validation for cuffless blood pressure monitors. 5-8+ years medical device quality engineering experience required. Equity program, competitive compensation.
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Anforderungen
- 5–8+ years quality engineering or manufacturing experience in medical device industry
- Hands-on experience with finished medical devices
- Strong experience with contract manufacturing environments
- Bachelor’s degree in technical or scientific field
- Solid knowledge of medical device regulations (MDR, ISO 13485, ISO 14971, FDA 21 CFR Part 820)
- Experience with risk management processes (e.g., process and design FMEA)
- Familiarity with QMS systems and audit processes
- Strong ownership and independent work ability
- Proven ability to lead cross-functional initiatives
- Excellent problem-solving skills with structured, analytical approach
- Ability to manage multiple priorities in dynamic environment
- Proficiency with MS Teams, Word, Excel, and PowerPoint
- Experience with eQMS systems and modern digital tools (including AI-supported workflows)
- Strong project and time management skills
Aufgaben
- Partner with manufacturing teams and contract manufacturers on quality engineering activities
- Drive and support process validations (IQ, OQ, PQ)
- Drive and support test method validations
- Ensure robust manufacturing process controls
- Lead continuous improvement initiatives for manufacturing processes
- Resolve non-conformances
- Ensure effective root cause analysis and corrective actions
- Lead cross-functional efforts to investigate and resolve quality issues
- Own and drive CAPA processes
- Ensure timely and effective CAPA implementation
- Ensure ongoing compliance with QMS requirements
- Ensure ongoing compliance with regulatory standards
- Monitor quality system performance
- Identify areas for quality system improvement
- Review and approve LHRs
- Review and approve DHF deliverables
- Review and approve product releases
- Review and approve engineering change orders
- Ensure product documentation meets internal procedures
- Ensure product documentation meets regulatory expectations
- Support labeling reviews for compliance
- Support labeling reviews for usability requirements
- Lead supplier management activities
- Conduct supplier audits
- Qualify suppliers
- Assess contract manufacturer performance
- Collaborate with contract manufacturers on quality standards
- Drive improvements across contract manufacturing suppliers
- Enhance product quality and reliability with suppliers
- Work closely with development teams
- Work closely with operations teams
- Work closely with manufacturing teams
- Work closely with quality teams
- Act as a quality subject matter expert on projects
- Act as a quality subject matter expert on initiatives
- Support internal audits
- Support external audits
- Ensure readiness for audits
- Ensure successful audit outcomes
- Coach internal teams on GMP requirements
- Coach internal teams on QMS requirements
- Coach external partners on GMP requirements
- Coach external partners on QMS requirements
- Lead initiatives to improve product quality
- Lead initiatives to improve operational efficiency
- Promote a strong culture of quality
- Promote a strong culture of accountability
- Promote a strong culture of continuous improvement
- Identify opportunities to streamline processes
- Identify opportunities to increase scalability
Berufserfahrung
5 Jahre
Ausbildung
Bachelor-Abschluss
Sprachen
Englisch – verhandlungssicher
Tools & Technologien
MS TeamsWordExcelPowerPointeQMS systemsAI-supported workflows
Benefits
Attraktive Vergütung
- Competitive compensation
- Equity program
Von Nejo automatisch aufbereitet
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.
Zur Originalanzeige bei Hilo by AktiiaÜber das Unternehmen
HI
HealthcareNeuenburg
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.
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