OPEN POSITION: Medical Device Quality Assurance Specialist/Manager

30.11.2020

Are you looking to join a dynamic and innovation-driven start-up that is building a healthier future for us all? Askel Healthcare’s unique technology rebuilds damaged joint surfaces for pain-free movement. With our implantable medical device solution, patients can quickly regain normal levels of activity free of pain. The drive, competence and dedication of our people make us unique. Positive attitude towards life in its all shapes and colors – is the core value we live by. 

We are now looking for a Medical Device Quality Assurance Specialist/Manager to join our team in Tampere, Finland. 

Our vision is to provide everyone a good quality life free of pain. A good quality life is a life where you are not restricted by your body to do things you love. We aim to offer the best treatment option for early cartilage regeneration to prevent further joint degradation and osteoarthritis. We at Askel do not stop at treating symptoms; we go a step further and provide truly regenerative solutions for the long-term benefit of the patients.  

 

Greetings from your future manager: 

“We are looking for an experienced person to lead our quality operationsWe welcome you and your hands-on experience of medical device quality assurance to join the team in its amazing ride of bringing a novel treatment solution to the market.” – Dr Anne-Marie Haaparanta, Chief Technology Officer, Co-founder, Askel Healthcare 

 

What you’ll do: 

In this position you will be responsible for 

  • Designdeployment and maintenance of the Quality Management System according to ISO 13485 including (but not limited to): 

- Documentation Management 

- Internal Audits 

- CAPA 

- Non-Conformance Management 

- Change Control 

- Complaint Management 

- Supplier Management 

- Training 

  • Ensuring procedures, systems, and processes effectively meet the quality requirements and business needs 
  • Internal communication and process training 
  • Continuously improving the QMS in compliance with MDR and other requirements, e.g. developing and updating procedures for internal processes
  • Proposing and driving improvements to the QMS to streamline business processes 
  • Performing periodic Internal Audits 
  • Managing External Audits 
  • Maintaining current knowledge of FDA, European and other international regulations, guidance’s, and standards applicable to industry. Monitor and identify developments to the legislations and translate these to the company’s therapeutic area. 
  • Performing other work-related duties as assigned or required 

 

What is your professional profile: 

(Can you say ‘yes!’ to a bunch of these?) 

  • Minimum Master’s Degree in health care, biomedical sciences or engineering, life sciences or other relevant educational background 
  • At least 4 years of professional experience in quality management systems or in regulatory affairs relating to medical devices (preferably class III medical devices) 
  • Strong experience in project management and budgeting 
  • Broad working knowledge of MDR, ISO 13485 and/or other applicable regulations 
  • Experience in eQMS software is a plus 
  • Previous exposure to regulatory agency inspections 
  • We also value knowledge and experience in a) US regulatory requirements, b) orthopedics, c) company’s focused therapeutic area, d) what else should we value – you tell us! 

 

Who you are as a person: 

  • Attention to detail, commitment to quality, accuracy, efficiency, and consistency  
  • Possess a high degree of professionalism, maturity and confidentiality 
  • Excellent organization and management skills 
  • Effective communication skills, both verbal and written 
  • Results oriented 
  • Ability to work cross-functionally 
  • Ability to build relationships with external parties (regulatory agencies, consultants etc.) 
  • Motivated to work in a fast-paced, high accountability and somewhat ambiguous start-up environment 
  • Foster a culture of collaboration, partnership, teamwork, customer service, and a drive for change and continuous improvement 
  • Fluent written and spoken English, Finnish is seen as a benefit 
  • Willingness to travel 

 

This iwhat woffer for you: 

  • Meaningful job: Our work impacts the quality of life of millions of people and companion animals in future. We highlight the expertise of our personnel, the high quality of our products and the company values. 
  • Inspired and motivated team: We have highly skilled and dedicated workforce that works as a team to achieve our shared objectives. 
  • Development opportunities: With us you can build up your expertise. We provide opportunities to support your development throughout every stage of your career. The sky is the limit for your professional growth! 

 

Additional Information: 

  • For more information, please contact Anne-Marie Haaparanta, am.haaparanta@askelhealthcare.com, tel. +358 40 489 3843 
  • Preferable times for a call Thursday 10.12.2020 at 10:00-11:00 and Thursday 17.12.2020 at 10:00-11:00 (UTC+2) 
  • Please send your application letter, including salary request (max 1 page) and CV (max 2 pages, containing only information relevant to the position) as a pdf document to am.haaparanta@askelhealthcare.com at latest by 31.12.2020 
  • We will start going through the applications already during the application period, so please submit your application as soon as possible. 
  • It is essential that applicants hold entitlement to work in Finland 
  • The work title, responsibilities and compensation are negotiated based on the applicant’s previous experience 
<< Back