QMS / Compliance Manager (m/f/d)

  • KIRINUS Health
  • München, KIRINUS Digital
  • Voll/Teilzeit
  • Publiziert: 11.05.2021
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For our headquarters in Munich (or remote) we are looking for an experienced QMS / Compliance Manager (m/f/d) to join our team as soon as possible.

We are a healthtech startup in the mental health space. We are backed by one of the leading family-owned providers for psychosomatic care in Bavaria and are born out of the idea that digital services are key to tackling one of society’s biggest problems: Our mental wellbeing. That’s why we are building a next-generation multisided eMental Health platform that is designed to 1) accompany patients during their recovery and 2) support therapists in caring for their patients in the most effective and efficient way. 

Our software product has been classified as a medical device under MDD and we want to take the next step by extending our QMS to be ISO 13485 compliant.

Sounds good? Then help us further develop our QMS and apply highest quality standards for our software products and apply now.

Responsibilities

  • Manage the entire QMS including change control, supplier qualifications, training, documentation management, quality agreements, CAPA, investigations, risk management, customer complaints, management review etc.
  • Revise, write, and author policies and procedures to maintain compliance to requirements.
  • Lead and manage strategic QA tasks working with clinical and development teams.
  • Educate and train team members regarding their impact on quality.
  • Ensure compliance with applicable regulations including MDD/MDR, ISO 13485, IEC 62304, IEC 62366-1, ISO 14971 and the German DVG/DIGAV
  • Manage internal audit programs and report on findings.
  • Establish and implement metrics to support process improvements and predict trends.

Qualifications

  • A BA/BS in a scientific discipline
  • Proven success in a role focused on Software as a Medical Device (SaMD) Quality Systems; experience in digital therapeutics is an asset
  • Strong knowledge of MDD/MDR, ISO 13485, IEC 62304, IEC 62366-1, ISO 14971 and preferably the German DVG/DIGAV
  • Experience in managing Confluence as a QMS system
  • Excellent communication skills
  • Ability to thrive in a fast-paced, technical, and mission-focused environment

Benefits

  • KIRINUS Health is a family business, fast-growing and rooted in tradition. KIRINUS has invested in health companies before and we are now building the first venture from scratch. With us, you get to build something from the ground up but also enjoy long-lasting support by Ideamed.
  • You will receive a competitive salary.
  • We are building a culture of accountability, speed and direct, critical feedback that is designed for A players that want to take real ownership of meaningful tasks. You will be a key part of honing and refining this culture.
  • We have an office in central Munich, where you will spend most of your time, but remote work  is not an issue.
  • A high level of commitment and dedication require you to take a breather every once in a while: 30 days of vacation p.a. are at your disposal.

We look forward to receiving your convincing CV, stating your annual salary expectations.

Contact

KIRINUS Digital
Nymphenburger Straße 148
80634 München
  • Herr Christoph Herbert