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HIHilo by Aktiia
Sr. Quality Engineer - Product Development(m/w/x)
Vollzeitmit HomeofficeSenior
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Leading design assurance for new medical device development, ensuring compliance with risk management. 5-8 years of quality engineering experience in the medical device industry required. Flexible work location, hybrid schedule, occasional international travel.
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Anforderungen
- Bachelor's degree in Engineering, Life Sciences, or technical discipline
- Advanced degree is a plus
- 5–8 years of experience in Quality Engineering, Design Assurance, or Product Development Quality
- Experience in the medical device industry
- Experience supporting new product development from concept through commercialization
- Experience under Design Control requirements
- Strong working knowledge of medical device Quality System Regulations
- Strong working knowledge of international standards
- Experience with design changes, sustaining engineering, and lifecycle management
- Experience with commercial medical devices
- Strong understanding of Design Controls
- Strong understanding of Design Reviews
- Strong understanding of Design Verification & Validation
- Strong understanding of Risk Management
- Strong understanding of Design Transfer
- Experience as Design Assurance or Quality Engineering SME during audits
- Demonstrated ability to lead cross-functional teams
- Ability to influence technical decisions without direct authority
- Strong project management skills
- Strong organizational skills
- Strong prioritization skills
- Ability to manage multiple projects simultaneously
- Strong analytical skills
- Strong problem-solving skills
- Experience facilitating risk-based decision making
- Excellent written communication skills
- Excellent verbal communication skills
- Proficient with Microsoft Office applications
- Proficient with electronic Quality Management Systems (eQMS)
- Proficient with Product Lifecycle Management (PLM) systems
- Self-motivated
- Collaborative, hands-on approach
- Ability to thrive in a fast-paced product development environment
Aufgaben
- Partner with cross-functional teams for new product development
- Provide Quality leadership in product development lifecycle
- Ensure compliance with design control and risk management requirements
- Lead Design Assurance activities including planning and reviews
- Review design documentation for completeness and traceability
- Ensure Design History Files and technical documentation are compliant
- Oversee engineering change activities and assess impacts
- Identify and monitor product risks with engineering teams
- Support Quality Management System activities and audits
- Drive a culture of quality through coaching and training
- Collaborate with Regulatory Affairs for global submissions
- Identify process improvement opportunities through metrics
- Serve as Design Assurance SME during regulatory assessments
Berufserfahrung
5 - 8 Jahre
Ausbildung
Bachelor-AbschlussODER
Master-Abschluss
Sprachen
Englisch – verhandlungssicher
Tools & Technologien
ISO 13485FDA 21 CFR Part 820 / QMSRISO 14971EU MDRIEC 62366IEC 60601IEC 62304Microsoft Officeelectronic Quality Management Systems (eQMS)Product Lifecycle Management (PLM) systems
Benefits
Flexibles Arbeiten
- Flexible work location
- Hybrid work schedule
Sonstige Vorteile
- Occasional international travel
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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