As a Quality Manager – Medical, you will be in charge of Nokia Digital Health Quality Management System based on ISO 13485, FDA 21CFR part 820, ISO 14971 and IEC 62304 for medical devices.
You will follow the product development from its concept phase to its launch and will support all teams involved on the product life cycle in order to ensure our products are compliant with the medical standards.
You will closely work with our Engineering team, Product Manager team and our Software and Hardware Quality.
Key responsibilities :
– Quality Management System (QMS), implementation, coordination and maintenance in accordance with international and industry standards.
– Maintain and organize the company’s internal quality audit program, management reviews and manage corrective and preventive action plans
– Responsible for coordinating audits by external parties (notified bodies), act as the organization’s Quality Management representative during audits.
– Report to the Management team on the performance of the QMS, including identifying needs for improvement.
– Track customer complaints/enquiries in order to ensure effective resolution and establish trends and corrective action plans.
– Provide support to the product team for existing and future products
– Assist in performing risk analysis on products for the CE/FDA certification
– Conduct supplier audits and assessments according to the QMS procedure
– Train all staff on the requirements of the QMS related to their own roles and responsibilities.
Masters’ degree in Engineering or Quality preferred, but experience will be evaluated in lieu of a degree
Working experience of quality in the medical device industry (ISO 13485, FDA 21CFR part 820, ISO 14971 and IEC 62304).
Three to five years’ quality management experience in a multi-project environment
Strong documentation, oral, and interpersonal communication skills.
Fluent in English, French would be a plus
High-energy and enthusiasm for working in a fast-paced, cross-cultural environment
Tenacious, energetic approach to matters.
Nokia Technologies develops advanced consumer and professional technology products in Digital Health and Digital Media, and licenses our industry-leading innovations as well as the Nokia brand for mobile devices. Nokia Technologies is determined to explore, discover and develop the ways in which technology can transform our lives.