Quality Assurance Manager

Pacertool

Quality Assurance Manager

Pacertool is solving a 20-year-old problem to understand how to effectively measure the underlying mechanisms for the development of dyssynchronous heart failure. 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. 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 has a track record of supporting other successful Norwegian biotech and medical device companies. For more information, please visit www.pacertool.com.

Join the Pacertool team to develop a breakthrough medical device that can help thousands of heart failure patients per year!

We are dedicated to making a difference for our patients and the healthcare systems around the world.

To achieve our vision and to take the next step in our journey we are recruiting a:

Quality Assurance Manager

The Quality Assurance Manager is responsible for quality assurance activities related to Pacertool’s R&D and regulatory compliance of medical devices. The Quality Assurance Manager will research, recommend, and implement best practices, and contribute to the regulatory affairs’ strategic and operational functions. The Quality Assurance Manager could be based anywhere in Europe, coming to the Norwegian office as needed and 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, ISO 13485, FDA CRF title 21 part 820, ISO 14971, and other relevant standards.
  • Monitor that all documentation for all development projects is created and maintained according to the company project plan.
  • Establishing and maintaining the document control and records management process, in alignment 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.

Skills and Qualifications

  • 5+ years of experience in Quality Management Systems relating to class II-III medical devices
  • Understanding of regulatory affairs in the EU and US
  • Excellent verbal and written communication abilities
  • Attention to detail and critical thinking
  • Able to deal with several projects at the same time

Who are you?

As a person, you are reliable, organized, unpretentious and professional. You are result-oriented and not afraid to roll up your sleeves in everyday work. You are a good team player, a “flexible hands-on doer” and you value cooperation and always show responsibility for your own work and for contributing to a good collaboration with others. You have a strong communicative ability and are fluent in English in speech and writing. You have an entrepreneurial mindset with a high interest to work in a small and passionate team. You inspire others through your dedication and your passion, and you create a culture of ownership and commitment in your environment.

To apply

This recruitment is handled by H&P Search & Interim. Please contact us for more information. Alternatively, you can apply directly by uploading your resume and sending us an email.

We look forward to your application!

H&P Search & Interim

Torbjörn Ströberg, torbjorn.stroberg@hpsearch.se, tel 0703-778 774

Catharina Bergold, catharina.bergold@hpsearch.se, tel 0702-179 879

Johan Walde, johan.walde@hpsearch.se, tel 0761-870 612

Karin Tomin, Karin.tomin@hpsearch.se, tel 0726-013 619