Medical Device Quality Management
- Quality Assurance Specialist
The QA is responsible for quality assurance activities related to Pacertool’s R&D and regulatory compliance of medical devices. The QA Specialist will research, recommend, and implement best practices, and contribute to the regulatory affairs' strategic and operational functions. The QA Specialist reports to the co-Founder & COO.
Duties and responsibilities
- Ensure that quality system requirements are effectively managed and maintained in accordance with all applicable medical device regulations and standards, including ISO 13485 and ISO 14971, and other applicable standards.
- Maintaining the document control and records management process aligned with applicable regulations.
- Create and maintain regular lines of communication with all employees to promote quality awareness, regulatory partnership, and harmonization of quality processes.
- Implement, monitor, and track standardized quality training to ensure employees have been trained on the Quality Management System.
- Coordinate internal audits and guide best practices and continuous improvement.
- Prepare medical device adverse and field corrective actions reports and recall notifications.
- Support the submittal of registration applications including IDE, 510(k), PMA, CE Mark, and other related regulatory filings.
Additional responsibilities may be assigned.
Skills and Qualifications
- Knowledge of quality assurance terminology, methods, and tools
- Experience in Regulatory Affairs and Quality Management Systems relating to medical devices
- Excellent verbal and written communication abilities
- Attention to detail
- Critical thinking
- Able to deal with several projects at the same time
What we offer
- Compensation on-par with the industry
- Office space at Aleap, Norway's largest community for health startups
- Flexible working time and location
- Opportunity to learn transferrable skills and room to grow with the company
- Yearly training in relevant technologies and tasks
- Optional traveling to relevant conferences
Pacertool is solving a 20-year-old problem for heart failure patients: the ability to improve the outcome of biventricular pacemaker implantations (CRT). Pacertool aims to be the first to market in the US and Europe with a proprietary medical device to address this unmet medical need.
Currently, 30-50% of the heart failure patients needing resynchronization have no effect of a CRT implantation and around 10% of the patients are feeling worse after the implant. This affects around 40,000 patients per year and constitutes an estimated annual burden of more than USD 1B to the healthcare systems in the US and Europe. Promoting value-based healthcare, Pacertool has the potential to reduce these costs and at the same time increase the market and effectiveness of the biventricular pacemakers being implanted.
Pacertool will over the next years complete the development of the Pacertool system and enter clinical and regulatory processes to validate the technology. The company targets the US market with a staged regulatory strategy establishing early clinical data and reimbursement for the technology.
The company was founded by Dr. Hans Henrik Odland in 2019 and has completed the first clinical proof-of-principle clinical trial in 45 heart failure patients. Pacertool has established a dedicated team of medical device professionals in Oslo, Norway. The team has a deep understanding of R&D processes for SW, hardware, and advanced intracardiac electrophysiology catheters.
We are dedicated to making a difference for our patients and the healthcare systems around the world.
Pacertool has recently closed a seed financing round supported by a prominent Norwegian investor consortium: TD Veen/p53, Sarsia Seed and the Rasmussen Group. The company has also received public funding through the Norwegian Research Council, Innovation Norway and the European Union.
Our investors have a long-term perspective of building a successful medical device company and have a track record of supporting other successful Norwegian biotech and medical device companies such as Nykode (Vaccibody) and BerGenBio. In the words of TD Veen/p53: “We seek to contribute to the development and commercialization of groundbreaking ideas that will increase accessibility to cutting-edge treatments and innovative solutions with a positive effect on the quality of life and well-being”.
- Gaustadallèen 21, 0349 Oslo
- Medisinsk utstyr og rekvisita
qa, qualitymanagement, risk management, biomedical engineering, document control
|Sist endret||5. jul. 2022 10:16|