Clinical Operations Quality Engineer

Il y a 6 mois


Grenoble, France Kayentis Temps plein

**KAYE** **NTIS** is a software solutions provider specialized in clinical trials.

Our c ore competence is in patient data capture and processing solutions (eClinical Outcome Assessments = eCOA) and

we a re now expanding towards Decentralized Trials functionalities.

With 16 years of global experience in eCOA, Kayentis has supported more than **260 clinical trials** in **79 countries** with

more than **90,000 patients**. Its head office is located in Meylan, near **Grenoble **(France), Kayentis is also present in

**Bosto** **n** (USA) and **Tokyo **(Japan).

Joining Kayentis' teams means choosing a fast-growing company committed to improving clinical trials and the **well-**

**being of its employees**.

**KAYE** **NTIS** is growing Develop your career with us

Join an international, cohesive and dynamic team and d** **evelop new skills

For more information about **Kayentis**, visit our career pa** **ge, or have a look at our employee satisfaction survey results.
Make sure to follow us on the social media platforms below for our latest news and updates:
**Clinical Operations Quality Engineer M/F
**The **Clinical Operations Quality Engineer permanent position **is based in Meylan (Grenoble).

**YOUR ROLE**:
**As part of Kayentis Quality & Regulatory team, you contribute to the quality and reliability of**

**Kayentis Solutions by ensuring clinical study projects follow Good Clinical Practices and Kayentis**

**Quality Management System processes.**

Participate in the maintenance, continuous improvement, and training of processes related to

the provision of services, from study conception and validation through closure

Owns the deviation and issue management processes and its continuous improvement. Coach

study teams on deviations and issue handling

Assess issues for possible escalation into Problems and CAPAs; can lead or participate in CAPA

teams

Qualify, monitor and audit subcontractors and suppliers involved in the provision of services

Support client audits and client inspections

Escalate issues with Client Governance and Management as necessary

Track, trend and report KPIs on deviations and process quality

**YOUR PROFILE**:
Master 1 or Master 2 level or equivalent in quality or clinical management

Professional experience > 2 years in quality in a life science regulated environment

Experience managing deviations or quality management system processes

Excellent verbal communication and writing skills

Customer-oriented

Fluent in English

Preferred:
Experience in the pharmaceutical, medical device, or clinical field

Deviation and CAPA Management

**YOUR BENEFITS**:
Flexible working hours

Bonuses

Meal vouchers

Bike allowance

**Are you interested in this opportunity?



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