Innovations Assistant & Quality Management Support

Innovations Assistant & Quality Management Support - Vienna Based

- for medical technology company with in-vitro diagnostic devices.

We believe in a future where healthcare is more accessible. That's why we work with specialised, self-motivated minds to develop home testing systems that combine diagnostics technology with medical knowledge and data. In order to help us continue the great work towards future certifications, we are looking for an Innovations Assistant & Quality Management Support to join us in Vienna.

A little about your future role…

The innovations assistant & QM Support assists the QM team in ensuring that the product or service an organization provides is fit for purpose, is consistent and meets both external and internal requirements. This includes legal compliance and customer expectations.

Responsibilities:

• Assist in establishing and maintaining the company's quality procedures, standards, and specifications
• Assist in ensuring that manufacturing or production processes meet international and national standards
• Assist in defining quality procedures in conjunction with operating staff
• Assess the effectiveness of changes made
• Assist in team training and maintain the training management system
• Maintain and monitor the effectiveness of the document management system
• Assist in maintaining product document files and IMS documentation
• Maintain and monitor the effectiveness of the change management system

A little about you…

• 1+ years of quality management
• Business administration, quality management, law, or similar experience
• Experience in a medical device, biotech or pharmaceutical environment preferred
• Experience in working under ISO 9001:2015, ISO 13485:2016, ISO 62304:2006 and FDA 21 CFR Part 820 required
• Knowledge of applicable US and EU medical device regulations preferred, knowledge of other markets is value
• Fluent in English at a professional level; German and/or other languages are advantageous
• Well-organised with a high level of attention to detail and accuracy
• Efficient project management is your second nature
• Have a positive and resilient attitude, even when encountering problems or when things go haywire
• Comfortable working both independently and on a team, within a fast-paced and flexible startup environment

Don't have experience with all the points above?

Don't worry, we are big fans of learning, training and coaching on the job. Shoot us an email and explain how we can help each other grow.

A little about us…

Bloom is an international company, with home bases in Zurich and Vienna. We are closely affiliated with venture-capitalists in Europe and overseas. Our team has proven experience in the European health tech, home-testing and medical research sectors and a proven track record of resilience in the competitive startup scene.

We value self-motivation and self-awareness, entrepreneurship, long-term thinking and collaborative teamwork. We are in the healthcare space and this requires us to constantly reflect upon how we impact the lives of our users. After all, we care for their health.

What we can offer you:

• Flexible work hours and ability to organise home-office days.
• Flat-hierarchy, with an open communication style and feedback.
• Team activities and outings (hiking, team retreats, etc.).
• Working with an internationally diverse, young and dynamic team
• Spacious office in 1st district Vienna, free coffee and tea and fruit
• Yearly Vienna transit card.
• An international work environment with English as the working language.
• Opportunity to contribute to a future where healthcare will be more prevention-focused and patient-centered

Like what you read?

To apply, send us an email at recruitment@bloomdiagnostics.com! We are proud of our diverse and international team and are an equal opportunity employer, meaning we don't discriminate in our hiring based on age, gender, race, or anything else.

We look forward to receiving your cover letter and CV.

Please note: When you apply with us @bloom diagnostics we will process and store the personal information that you have provided us with for the purpose of handling your application. We will store your contact details only if you instruct us to do so, otherwise your application data is deleted once our hiring process has finalised. If you have any further questions regarding how we handle our data, do not hesitate to reach out to office@bloomdiagnostics.com.

Salary

Our salary range starts upwards from EUR33,000 gross per year as a full time position based in Vienna. Depending on what skills and experience you bring with you, this is the least we would pay.

Annotation: According to the Federal Collective Bargaining Agreement (Rahmenkollektivvertrag für Angestellte im Handwerk und Gewerbe: www.wko.at), the salary class for this position is class II, depending on experience also of the successful candidate.