Quality Manager Quality Management

_Full Time (Vienna)_

Diabetes is a pesky monster — and that's putting it mildly. If you're serious about helping us face it head on, come join us

For a behind-the-scenes look, check out our Monster Culture blog, this little video and Roche code4life to see what makes mySugr and Roche tick.

**Here's what we're looking for**:
We are looking for a Quality Manager in the area of Medical Device Quality Management (ISO 13485). Our software apps are updated every other week thereby requiring lean and effective processes. As we are often pioneers in our field, we need a pragmatic person who is eager to expand into new fields of products and services. mySugr currently has class IIa and IIb products on the market and is ISO 13485, MDSAP, and ISO27001 certified; as a Quality Manager, you will support the improvement and implementation of processes of our Quality Management System and help ensure compliance in record generation.

**Essential skills for your mission**:

- Working knowledge of Regulations and standards for Medical Device Quality Management and Software Development (Medical Device Regulation (EU) 2017/745, ISO 13485, IEC 62304 and IEC 82304)
- Experience participating in Notified Body and/or FDA audits
- Experience in working on overlapping projects - i.e. good at managing the needs of multiple initiatives, multitasking and organizing yourself
- Experience in optimizing existing processes to work for multiple regulatory jurisdictions and at the same time minimizing impact on daily work as far as possible
- Ability to translate quality and regulatory requirements into practical implementations for the organization
- Excellent written and verbal communication skills in English
- Enjoy learning new things and thinking outside the box
- Willingness to working in cross functional and cross organizational teams for knowledge sharing and constant simplification

**Bonus skills**:

- Knowledge of the diabetes industry or other comparable health industries
- Technical understanding and love for innovative apps or software development
- Experience in ISO 27001 and MDSAP
- Experience working in agile environments

**What to expect**:

- Ambitious and passionate people building meaningful products
- An innovative agile working environment allowing for collaboration with really smart people and knowledge sharing in cross-functional teams
- A growing organization with room for development
- Not a corporate environment, but the leverage of a global market leader (Roche family)
- Loads of benefits (brand new Apple hardware, fitness, public transport, lunch benefit, language classes, professional training budget, chance to join global conferences...)
- Flexible working hours, home office policy and 5 weeks vacation
- A kick-ass office with a rooftop terrace, fully stocked kitchen and amazing barista coffee machines in the middle of Viennaoh, and did we mention the best team in the world

**Who we are and what we care about**:
Here at mySugr and Roche Diabetes Care we are committed to providing a healthy, equal and inclusive working environment for our Monster Tamers to help them make diabetes suck less We care about family friendly career paths, sustainability, a healthy lifestyle and the flexibility of a modern workplace. We maintain a culture of learning and sharing, as well as open and candid feedback. At every level, there are many opportunities to develop and grow at mySugr - both professionally and personally.

Being a global leader in integrated Personalised Diabetes Management (iPDM), Roche Diabetes Care collaborates with pioneers around the globe, including people with diabetes, caregivers, healthcare providers and payers. We aim to transform and advance care provision and foster sustainable care structures. Under the brands RocheDiabetes, Accu-Chek and mySugr, comprising glucose monitoring, insulin delivery systems and digital solutions, we unite with our partners to create patient-centred value. By building and collaborating in an open ecosystem, connecting devices and digital solutions as well as contextualising relevant data points, we enable deeper insights and a better understanding of diabetes, leading to personalised and effective therapy adjustments.

Make sure to read our Privacy Notice for Applicants.