Senior QA Specialist (m/f/x)

At Cara Care we are looking for a Senior QA Specialist (m/f/x) for our team in Germany. You will work remotely and can be located anywhere in Germany. For this role we are looking for a person who is enthusiastic, self-motivated, has great communication skills and can create and support the Quality Management System (QMS) aspects through management of the Quality Assurance infrastructure as well as facilitation of compliance and certification activities. In this role you will thrive in an energetic, fast-paced environment, working with highly motivated and passionate people. You should be comfortable in a rapidly evolving Software as a Medical Device (SaMD) start-up environment assisting in the implementation of a value added QMS based on EU MDR,  ISO 13485:2016, and ISO 14971:2019 for product(s) intended for Germany and/or EU release. As half of our team is working from the US you will require a bit of flexibility in terms of working outside of standard business hours (around 10% of your time) due to some differences in time zones. 

Requirements

🦸‍♂️ Your Responsibilities

• You own, administer, maintain, and improve the Quality Management System (acc. to ISO 13485:2016). This includes tasks such as Document Control, Training records, non-conformance resolution / CAPA, Post Market Surveillance, Internal and external auditing, providing guidance to other team members on the regulations 
• You review, edit, verify and create the EU MDR Technical Documentation of our medical devices (including the Risk Management File according to ISO 14971:2019) 
• You provide guidance to other team members on the quality system use to improve and ensure training compliance or follow up on action items from QMS outputs
• You support internal audits and are responsible for the gap assessment as well as the closure of action items related to the periodic QMS internal audits 
• You support the periodic supplier management audits 
• You assist in building and/or revamping quality systems. You create or update corresponding standard operating procedures as per EU MDR, ISO 13485:2016, ISO 14971:2019, ISO 27001 and any other adopted regulatory standards
• You collaborate with other department representatives to follow up on action items for change implementations

🧳 Your Profile

• 3+ years relevant work experience in quality management and regulatory affairs, in the medical / healthcare industry, ideally in DiGA or other stand-alone software. Work experience in a startup is a strong plus but not a must-have 
• University degree in IT, medicine, engineering, or similar field
• Profound knowledge of regulatory standards (EU-MDR (EU 2017/745), ISO 13485:2016 and ISO 14971:2019) and the Medical Device Regulation. Knowledge of ISO 27001 is a plus but not a must-have 
• Experience in implementing or improving new Quality processes for Medical Device companies
• Openness and good technical skills for the use of software tools such as Slack, GSuite and Confluence / Jira 
• Strong Project Management skills owning regulatory processes working closely with software development, clinical and business teams
• Strong interpersonal skills to be able to facilitate interactions and communication with other teams
• Work in a reliable, precise, and solution-oriented way
• Excellent communication skills both written and spoken in English and German
• A high independence and hands-on mentality.

Benefits

⭐️ In return you will have:

• Great team spirit: a vibrant team and a friendly working atmosphere + regular team events 
• Remote work setup: we understand the importance of flexibility in a work setup and therefore give you the opportunity to work remotely from home
• 30 days off per year: we believe that regular breaks are important and therefore offer 4 additional company wide mental health days on top of the 26 regular holidays
• Flexible working hours: an early start into the day or late finishes, you decide
• Impact: your contribution matters – the ability to significantly influence the direction of our startup
• Fair Compensation: competitive salary with regularly salary reviews and equity option + the best equipment to be productive

About Cara Care 

Cara Care is an app that provides holistic support for people with digestive issues. Cara Care puts each affected individual into focus. With the help of Cara Care, individuals are able to identify factors that influence their symptoms. They also receive personalized recommendations and exercises – backed by science.

By downloading the Cara Care app, individuals can choose from three medical devices to receive support for conditions such as irritable bowel syndrome (Cara Care for IBS), inflammatory bowel disease (Cara Care for IBD), or heartburn-related indications (Cara Care for Heartburn). With Cara Care for IBS being approved by the German Federal Institute for Drugs and Medical Devices as a digital health application, individuals are now able to profit from the first reimbursable digital IBS therapeutic.

What it is like to work with us

We are an interdisciplinary team of doctors, designers and software engineers who are all passionate about what we are building and how it can help people. Our work is inspired by our patient’s journey and our actions are focused on impact and results. We thrive in a dynamic, fast-paced work environment, while appreciating what it means to be healthy and well.  

To learn a bit more about our motivation, our team and company, you can visit our career page: https://cara.care/de/careers/ 

At Cara Care we care about equal opportunities

Diversity is important to us. We need a team with a variety of different perspectives, experiences and backgrounds. That’s why we’re committed to hiring people regardless of race, religion, colour, national origin, sex, sexual orientation, gender identity, age or disability.

We understand that applying for a new job takes a lot of work and we really value your time. Our team is looking forward to reading your application!