Quality Management System Specialist / QMR

(f/m/d)

BHS Technologies is a medical technology company based in Kematen in Tirol. We develop, manufacture and market technologies that support surgeons and medical professionals in their daily work in the OR.

 

As Quality Management System Specialist, you run our management system in line with ISO 13485 and the MDR, and develop it further towards business excellence. You are the first point of contact for our Notified Body, authorities and auditors, help shape the digitalisation of our processes and prepare input for our strategy process. You report directly to the Management and work closely with Regulatory Affairs, R&D and all departments. 

  • Areas of Responsibility

  • 01

    Management system

    You run and develop the QMS according to ISO 13485 and the MDR, including the quality manual, SOPs and document control, integrate further requirements, and train employees on the integrated management system. 

  • 02

    Audits

    You plan and conduct internal audits as well as partner and supplier audits as Lead Auditor, and support external audits by the Notified Body. 

  • 03

    Business excellence & strategy

    You drive the company’s development as part of a continuous improvement cycle, prepare content for the strategy process and support senior management in defining and compiling quality targets and KPIs as part of the management review process. 

  • 04

    Standards & regulation

    You keep all applicable standards and laws up to date, follow international trends in management and regulation, and advise the whole company on them. 

  • 05

    CAPA & change

    You initiate and supervise corrective and preventive actions and changes to the management system and its manual. 

  • 06

    Product development

    You participate in R&D design controls, quality gates and risk management according to ISO 14971. 

  • 07

    Culture & Management Cockpit

    You maintain and further develop our Management Cockpit as a steering tool for management, support People & Culture Manager with the analysis of the quarterly employee survey as our internal feedback system. 

Your Profile

  • Degree (university or university of applied sciences) in engineering, natural sciences, medical technology or industrial engineering – or an equivalent qualification with relevant experience
  • At least 5 years of experience in quality management, ideally at a medical device manufacturer 
  • In-depth knowledge and experience in dealing with and implementing standards and regulations 
  • Experience in the further development of integrated management systems within a complex and wide landscape of international standards and regulations 
  • Certified QM training (e.g. Quality Austria, TÜV) and experience in conducting audits 
  • Fluent in Project Management  
  • Confident with common Office Software and ticket systems (e.g. Jira) 
  • Process thinking, structure and a high degree of flexibility on technical questions – you implement requirements pragmatically: as much as necessary, as lean as possible 
  • Strong communication skills, assertiveness and enthusiasm for getting people excited about importance and meaning of quality 
  • Very good German and English (main languages spoken in the company) 

Nice to Have

  • Solid knowledge of ISO 13485 and the MDR, as well as ISO/IEC 27001, ISO 37301, EFQM or MDSAP
  • Auditor qualification according to ISO 19011  
  • Experience with Confluence, ALM tools (e.g. Jama Connect) and computer system validation 
  • Experience with Notified Body audits 
  • Experience in start-ups or fast-growing organisations 

Your future working environment

At BHS Technologies, we highly value teamwork and appreciate every opinion. Therefore, decisions are made together and your opinion counts from day one!

 

Our communication is open, questioning the status quo is our daily business. The characters and interests in our team are diverse and colorful, and we all work together to ensure that there is enough freedom for each character. What we do together is varied, very challenging and above all: very interesting!

The BHS Team

BHS Technologies is a team of people who work closely together and support each other in everyday work. Collaboration, open exchange and mutual trust shape how we approach tasks and solve challenges as a group.

Beyond daily work, team members regularly connect outside the office, whether through shared activities, informal gatherings or time spent together after work.

 
 

The BHS Leadership Team

BHS Technologies is led by Michael Schmid-Santek, CEO, Gregor Burger, CTO Software and Mark Capelli, CTO Hardware. The leadership team works closely with employees across teams, values direct communication and supports collaboration between development, service and commercial functions.

Our Perks

  • A genuine work-life balance. We are based in Innsbruck, the mountains are on our doorstep, and we make full use of them. Ski touring in the morning, road cycling at lunch, hiking after work. Nothing is mandatory, everything is welcome.

  • Flexible working hours and the option to work remotely,  your schedule built around your life, not the other way around.

  • A vivid team culture with regular events at and outside the office.

  • Professional coffee corner, because life is too short for bad office coffee! We’ll teach you to make best cappuccinos! 

  • Food delivery when you don’t feel like cooking, or a fully equipped kitchen when you do 

Have we made you curious?

Then apply directly using the contact form below!

Your contact person is Maria Volkova.

We are looking forward to receiving your application!

 

Your actual salary will depend on your training, professional experience and qualifications. The basic salary for this position is a minimum of € 55,594 gross/year according to the collective agreement (KV metal industry, job group IV, with at least 4 creditable years in the group). A fair overpayment in line with the market is important to us and will be agreed in a personal interview.

Apply

If you are interested in joining our team and being part of the microsurgical revolution, please send your application with this form:

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  • What happens after sending your application?

  • 1

    Confirmation notice

    Right after sending your application, you will receive a notification saying the upload and sending has been successful.

  • 2

    Response

    Shortly after sending your application you will hear from us – either per phone or per email. We let you know the estimated duration of the process and might ask you few detailed questions about your application.

  • 3

    Interview Invitation

    If your application has impressed us, we will invite you to an interview to get to know you better. 

  • 4

    Welcome to the BHS team!

    Your team leader will help you with the first steps. They show you everything that is important and make sure that you feel comfortable in our team.