Jr Quality
2 settimane fa
Welcome to ZimVie, a new, publicly traded global company focused on improving quality of life for our patients. Our company is founded on a legacy of established brands, medical experts and over $1B in annual revenue. We design, manufacture, and distribute a comprehensive portfolio of innovative solutions for implant dentistry, spinal surgery and bone growth stimulation. Our seasoned leadership and dedicated global team of more than 2,500 is focused on shaping an exciting future for ZimVie — we hope you’ll consider being a part of it_
**Job Mission**:
Perform duties in maintaining regulatory compliance for products marketed within the EU, FDA and MEA Countries with primary emphasis on communications to the Competent Authorities.
Support the Legal Manufacturer Activities through the maintenance and continuous improvement of the QMS according to EU MDR, FDA and ISO 13485:2016**.**
**Principal Duties and Responsibilities**:
- Support the maintenance and compliance of the Quality Management System and RA activities.
- Support maintenance, update and creation of TDs and 510(K) for Class I, and IIa surgical instruments, collaborating in the registration submissions with the EMEA team.
- Support in the Reporting and management of metrics (KPIs) at required meetings (e.g. CAPA Trigger, Management Review, complaints, NCs, calibration).
- Notify the Competent Authorities of any changes when needed according to instructions of EMEA HQ.
- Participation in internal and external audits and any responses to cited issues being the ownership of corrective actions stemming from these audits.
**Education/Experience Requirements**:
- 1-2 years in practical international medical device regulatory and quality experience.
- Demonstrated experience handling requirements of ISO 13485:2016 and EU MDR.
- Fluent in English & Italian. Other European languages, as Spanish is a plus.
- MS Office.
**Our offer**:
ZimVie offers you a challenging position with good career prospects in a fast growing international business. We offer a competitive remuneration package.
- Temporary contract
- Competitive fixed salary
- Meal allowance
- ZimVie is an Equal Opportunity Employer committed to diversity and inclusion in the workplace. All qualified applicants for employment and employment decisions, including hiring, promotion, transfer, etc. are considered without regard to racial or ethnic origin, gender, religion or belief, disability, age or sexual identity._
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