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Quality Assurance Specialist

Quality Assurance Specialist

locationVienna, Austria
location Other

Come and grow with a medical technology company!.

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. To support the realisation of this vision we are searching for an internationally-minded Quality Assurance Specialist to join our growing team. That’s where you come in.

A little about your future role…

We offer a permanent position, based in Vienna, where you can grow professionally in an innovative, open, diverse and future-oriented startup environment. You will:

  • Take ownership of all QA relevant aspects of our IMS
  • Take responsibility in ensuring quality of our Products and Processes in close cooperation with Manufacturing
  • Support operational Purchasing and Supplier Management 
  • Oversee & take an active role in Product Change Management, Software Validation, Supplier Corrective Actions (SCARs) & CAPA Management
  • Analyze audit outcomes and carry out appropriate corrective procedures
  • Perform routine audits (internal & external) and quality tests.
  • Identify and resolve workflow and production issues.
  • Address and discuss issues and proposed solutions with superiors.
  • Document quality assurance activities
  • Make recommendations for improvement.
  • Monitor and maintenance of existing processes 
  • Recording, analysing and distributing statistical information monitoring performance (KPI System)
  • Gather and organize statistical quality data

A little about you…

  • Master’s degree in a related technical field.
  • Certificate in quality assurance and/or Quality Management is a plus.
  • At least 3 years’ practical, hands-on experience working in Quality Management or Quality Assurance in a regulated environment
  • Experience in a medical device, biotech or pharmaceutical manufacturing environment 
  • Working knowledge of tools, methods, and concepts of quality assurance.
  • Working knowledge of ISO 13485 and GMP and other recognized international quality system standards.
  • ISO9001, Regulation (EU) 2017/746, ISO14971, 21CFR820 and MDSAP a plus
  • Experience with Audits (as Auditor & Auditee) 
  • Excellent data collection and analysis skills.
  • Good communication skills, both verbal and written.
  • Strong attention to detail.
  • A desire to help others achieve their best.
  • Excellent interpersonal skills and ability to work with others in a positive and collaborative manner
  • Knowledge of JIRA, Confluence is a plus
  • Knowledge and/or of Quality Methods like LEAN or Six Sigma is a plus
  • Fluent in English and German at a professional level; other languages are advantageous
  • Well-organised with a high level of attention to detail and accuracy
  • Have a positive and resilient attitude, even when encountering problems or when things go haywire
  • Comfortable working remote and both independently and on a team, within a fast-paced and flexible startup environment
  • Required work permit for working in Austria

A little about us…

Bloom is an international company, with home bases in Zurich and Vienna. Our team has proven experience in the European healthtech, 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:

  • Working in a next-generation healthtech company, building and scaling a market from anew
  • Flexible work hours and ability to organise home-office days.
  • Flat-hierarchy, with an open communication style and feedback.
  • Team activities
  • Working with an internationally diverse, young and dynamic team where English is the company language
  • Spacious office in 1st district Vienna (with awesome places to go for lunch and after work drinks), free coffee and tea and fruit
  • Yearly Vienna transit card.
  • Opportunity to contribute to a future where healthcare will be more prevention-focused and patient-centered

Salary

For this full-time position, we offer a competitive, annual gross salary starting at € 48.000, negotiable and is the very least we would pay, depending on your skills and experience.