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Quality Assurance Specialist

Inofab Health is a growing digital health company that has a passion for designing solutions for patients with Asthma, COPD, CF, and other chronic lung conditions.

As Inofab Heros, we create value for both doctors and patients through hardware-integrated software solutions that are rapidly becoming the inevitable future of respiratory care.

Inofab Health has brought to market the world’s first ultrasonic personal spirometer SpiroHome which has reached patients in over 51 countries since May 2019.

It is continuing to expand its product range with SpiroCloud (a remote patient monitoring software), SpiroClinic (smart spirometer for professional use) and Spirohaler (smart inhaler sensors to improve patient adherence).

What you will do at Inofab

  • Coordinating and preparing Quality-related files
  • Ensuring regulatory compliance in both internal and external company operations (i.e. manufacturing, product development, etc.)
  • Leading the R&D team in the development of product technical files
  • Defining, establishing, and applying operating procedures.
  • Coaching and monitoring personnel through the application of quality procedures.
  • Providing technical support in organizational development and regulatory issues

Qualifications

  • Effective communication skills in written and verbal English,
  • Deep understanding of Quality Management Systems ISO13485, ISO9001. Knowledge in MDSAP & FDA CFR21 Part 820 is a huge plus
  • Past experience in technical dossier preparation is a huge plus
  • Knowledge of International standards ISO 13485, ISO 14971, ISO 62304
  • Experience in the medical device industry
  • Ability to take initiative and work autonomously
  • A natural curiosity about trends in medical technology
  • Solid knowledge of computer skills in Google Workspace Products-Sheets,Slides,Docs- (Jira and Confluence knowledge would be an asset)
  • Must have strong organizational and planning skills
  • Prior experience in startups will be considered an important asset

Working as a Inofab Hero

  • Forward-thinking, transparent, and inclusive company culture
  • Collaborative environment within across our R&D, business, quality & operation teams and at our Ankara Headquarters
  • Private Health Insurance
  • Meal Card for your tastes and preferences
  • Flexible working hours with partially remote options
  • Stock option plans
  • A competitive salary with a bonus scheme
  • Flexible dress code

The Recruiting Process

We are committed to keeping our recruitment process short and transparent. Here’s what it looks like:

  • Application: Send us your CV or LinkedIn profile. You can also include a few words about yourself and your motivations.
  • Interview: Let’s talk about your experience & expectations and see what we can achieve together.
  • Case study: We may need to test particular skills & experiences.
  • Welcome aboard! You are now a part of our team.

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If you believe that you are willing to become a partner of a fast-paced environment that targets to add value in the healthcare industry we are waiting for you!

As Inofab, we solemnly give importance for zero discrimination and strictly imply this as a workplace policy. Any applicants will be regarded as equals without considering any gender, ethnicity, nationality, religion, disability, citizenship, marital status, and any other distinct demographics.

Our hiring policy focuses on only reaching our the applicants that are suitable for the position and interview due to the large scale of applications. The applied candidates will be evaluated on an urgent manner following their submission.