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We provide a stimulating and enjoyable work–life environment and the opportunity to contribute to some of tomorrow’s most exciting medical breakthroughs. We have a collaborative working style that highlights teamwork and trust.
Our team is passionate about making a positive difference everyday. We are proud of what we do, together.
Want to make a difference? Join us today!
Open position: Sr. Quality Assurance, Italy
We are looking for a Sr. Quality Assurance Specialist, who will be responsible for the overall implementation and maintenance of InnovHeart’s Quality Management System (QMS) in the Colleretto site, reporting to the Quality Assurance VP. To this purpose she/he will coordinate efforts with InnovHeart interfaces based in the US Site and the Italian site, as well as with interfaces located outside of the InnovHeart organization.
- To develop, implement and maintain the Quality Assurance functions to support product development, manufacturing and other Quality System activities in the InnovHeart Italian site;
- to act as Management Representative (deputy) for the Company in the framework of the standard ISO 13485;
- to ensure that processes needed for the quality management system are established, implemented, maintained and documented;
- to report to Top Management on the effectiveness of the quality management system and any need for improvement;
- to promote awareness of applicable regulatory requirements and quality management system requirements throughout the organization;
- to act as a liaison with external parties on matters relating to the QMS;
- to approve waivers and Change Requests in accordance with the QMS procedures. He/she will have authority to suspend the release of non-conforming products and to launch corrective and preventive actions;
- to conducting audits and training.
- Minimum of five (5) years of experience in Quality Assurance or Quality Engineering in Medical Device industries, preferably with business in Class III implantable devices Knowledgeable of regulatory requirements of Medical Devices;
- Competence in ISO 13485:2016 and EU 2017/745 (MDR);
- QMS Auditor;
- Excellent organizational and time management skills;
- Effectiveness to achieve assigned objectives in low-structured environments;
- Fluency in English is mandatory.
Please send your application and resume to email@example.com.
“It doesn’t make sense to hire smart people and then tell them what to do;
we hire smart people so they can tell us what to do.”