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Full-time
bachelor degree
Flexible Hybrid Working Model, Professional Development Training, Personal Development Training, Individual Development Plans, Career Growth Opportunities
Posted 11d ago
~40 hrs/week
Responsibilities
Ensure medical device development complies with global quality standards, regulatory requirements, and internal processes. Drive design control, risk management, and root cause investigations to enhance product reliability and compliance.
Requirements
Requires a degree in Electronics, Software, Mechanical Engineering, or a related field with over 5 years of quality engineering experience in the medical device industry. Must be proficient in ISO 13485, ISO 14971, and fluent in English.
Full job description
As a Design Quality Assurance Engineer, you'll play a key role in ensuring our innovative medical device products are developed in compliance with global quality standards and regulatory requirements. Working closely with cross-functional R&D teams, you'll help drive robust design control, risk management, and quality processes throughout the product lifecycle. In return for your expertise and collaborative mindset, you'll have the opportunity to influence product quality from concept through launch while developing your career in a global, innovation-driven environment.
More about the role
Ensure development activities comply with internal quality processes, regulatory requirements, and industry standards
Review technical documentation, design changes, and engineering deliverables to support high-quality product development
Support Design Control, product risk management, and design verification activities throughout the development lifecycle
Collaborate with cross-functional project teams to identify quality risks early and drive continuous process improvements
Contribute to root cause investigations, CAPAs, and design improvements to enhance product reliability and compliance
Support process documentation, internal audits, and the successful delivery of projects in line with development plans
More about you
Degree in Electronics, Software, Mechanical Engineering, or a related technical discipline
5+ years of experience in a quality-related engineering role, ideally within the medical device industry
Practical experience with Design Control, Product Risk Management, and technical documentation review
Good knowledge of ISO 13485 and ISO 14971, with an understanding of medical device development processes
Strong analytical skills with the ability to communicate quality and regulatory requirements to diverse stakeholders
Fluent English, both written and spoken
More about what we offer
As one of the world’s leading hearing care providers headquartered in Switzerland, we’re committed to building an inclusive culture. We want to create an environment where you can balance a successful career with your commitments and interests outside of work, through our flexible hybrid working model. We offer a wide range of training opportunities for both your professional and personal development, and there are exceptional growth opportunities with individual development plans.
Please note: We only consider direct applications for this position.
We kindly ask all applicants to submit their résumé in English.
Related keywords
Medical DeviceDesign Quality AssuranceISO 13485ISO 14971Design ControlRisk ManagementCAPADesign VerificationRegulatory RequirementsRoot Cause AnalysisTechnical DocumentationQuality EngineeringHearing CareComplianceR&D
Around 25% of the world’s population is living with hearing loss. At Sonova, we envision a world where everyone enjoys the delight of hearing and lives a life without limitations. From personal audio devices and wireless communication systems to audiological care services, hearing aids, and cochlear implants. Our product brands – Phonak, Unitron, Sennheiser (under license), and Advanced Bionics – create compelling new products to offer the optimal solution for an ever growing consumer base through our globally diversified sales and distribution channels, including our well established global audiological care business. With a presence in over 100 countries and more than 19,000 employees, we leverage our global infrastructure and local roots. We aim for an inclusive work environment and culture that fosters a good balance of family and work-life for everyone. Our workforce is made up of 110 nationalities across 4 generations.
In 2006, Sonova founded the non-profit Hear the World Foundation, which seeks to give children living with hearing loss access to audiological care in low- to middle-income countries.
Offices: Laubisrütistrasse 28, Stäfa, 8712, CH
Information TechnologyWearablesMedical DeviceCommunication HardwareWirelessCustomer ServiceConsumer ElectronicsManufacturing
How many Healthcare jobs are open in Barcelona, Spain right now?
There are currently 736 open healthcare positions in Barcelona, Spain listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Healthcare roles in Barcelona, Spain?
Companies currently hiring include Novartis, AstraZeneca, ICON plc, Sanofi, IQVIA, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Healthcare jobs in Barcelona, Spain?
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