Are you a self-driven quality assurance professional with experience in medical devices or in-vitro diagnostic devices? Does working at the forefront of life sciences and healthcare sound interesting to you?
Blueprint Genetics is one of the fastest growing clinical genetic testing companies for inherited diseases globally. We work with hundreds of clinics around the globe and the quality of our interpretation has been praised by many of the world’s best medical centers. As our company continues to grow, we are looking for a full-time Senior Quality Specialist to join our Quality Assurance and Regulatory Affairs team in Espoo, Finland.
We are looking for you, who wants to make a difference
As a Senior Quality Specialist, you will ensure that our medical device quality assurance processes meet relevant medical device regulations, including the new EU IVDR and MDR regulations. You will be working closely together with relevant teams and departments across the organization to improve our quality assurance processes and product quality. You will also coordinate design changes and review design control documentation. In this role, you will have the unique opportunity to be a part of building a quality management system in a global, high-growth company.
Your main tasks will include:
- Developing and maintaining medical device quality assurance processes to meet relevant regulations, including EU IVDR and MDR
- Supporting the development and execution of validation master plans, equipment qualifications, and process and test method validations for successful transfer from development to clinical laboratory and manufacturing
- Reviewing design control documentation and coordinating design changes
- Supporting the development and maintenance of the risk management process
- Supporting and participating in regulatory agency and customer quality audits
- Developing inspection methods to analyze product and service quality
- Performing data trend analysis to improve processes and products
- Supporting scientific, complaint, and other investigations
- Coordinating, in collaboration with other teams, nonconforming product and CAPA management to drive root cause analysis and practical corrective and preventive solutions
- Working with relevant teams and departments to improve processes and product quality
What we expect from you
We are hoping to find a team member who is a thorough and organized problem-solver. You take ownership of the tasks at hand and have a diplomatic approach to addressing quality issues. You have excellent communication skills and you enjoy working closely with others. We hope you feel at home in a fast-paced working environment and you have enthusiasm and curiosity to learn and grow with us.
Our ideal candidate has:
- A BSc and/or MSc from the field of life sciences or engineering
- A minimum of 3 years of experience with medical devices quality assurance
- A solid understanding of applicable (IVD) medical device regulations and
- Knowledge of equipment qualification, process validation, software validation, risk management, design and development activities
- Good interpersonal and communication skills
- Strong problem-solving skills
- Understanding of applicable regulations and industry standards regarding clinical laboratory, including ISO 15189, is an asset
What we offer
At Blueprint Genetics you will work with dedicated and innovative experts with versatile backgrounds, whilst having an opportunity to support industry-changing solutions that improve the lives of patients and families affected by inherited diseases. We offer you an open and collaborative work environment where you can learn and grow together with the company. You will join a growing team of five quality and regulatory experts.
If this sounds like you, take the next step and apply latest on Monday, May 10. We will be interviewing candidates on a rolling basis.
If you have any further questions about the position, you can contact our Quality Manager, Olli Mikkonen by email: email@example.com or by phone +358 40 846 8833 on April 22 at 13-16 (EET).