About Us
At oasicare, we are committed to developing solutions that enhance the standard of care for women. Our first product is a medical device designed to reduce the risk of perineal tears. Currently, we are in the development stage and are running initial pilot tests at a Danish maternity ward.
The Position
We are seeking a seasoned QA professional to Lead the creation and implementation of our QMS and make the company ISO 13485-ready. While patterning cross functionally, this position provides a unique opportunity to join a dynamic and fast-pace startup environment and truly be an architect of our QMS. We are looking at a candidate who will take the lead to create procedures, drive audits, push continuous improvement initiatives and contribute to the overall quality culture of the organization. This role involves overseeing audits, managing quality documentation, and driving continuous improvement across all quality-related activities.
Qualifications
- Bachelor’s or preferred master Degree in a relevant field such as Quality Management, Biomedical Engineering, Life Sciences, or a related technical discipline or preferably.
- A minimum of 5-7 years of experience in quality management within the medical device or medical device industry.
- In-depth understanding of regulatory requirements such as ISO 13485, CE marking, and other relevant standards.
- Expertise in managing QMS documentation, including the creation, revision, and approval of SOPs, quality manuals, and records.
- Proficiency in conducting risk assessments (e.g., FMEA) and implementing risk management strategies in accordance with ISO 14971.
- Ability to lead continuous improvement initiatives and manage corrective and preventive actions (CAPA) effectively.
- Certifications such as CQA, CQE, or ISO 13485 Lead Auditor preferred.
- Strong leadership, project management, and communication skills.
As a Person You:
- Thrive in a fast-paced, dynamic work environment.
- Are self-driven and work well independently but also collaborate effectively in a team.
- Systematically prioritize tasks in large projects.
- Demonstrate initiative and the ability to work independently.
- Are adaptable, resourceful, and flexible in handling changing project priorities.
Our Team
We are a dynamic and supportive team of seven, dedicated to bringing our device to market to improve women’s health postpartum by preventing severe birth complications. Our team is characterized by a strong international drive to enhance maternal health on a global scale. In daily work, you will experience a high degree of autonomy and empowerment in your role. Oasicare is supported by top Scandinavian biotechnology investors and the BioInnovation Institute (BII). Our offices are located in the heart of Vesterbro, Copenhagen. This job offers the chance to be part of a groundbreaking medical device development that could revolutionize the birth experience for millions of women annually.
We are committed to ensuring an inclusive recruitment process and providing equal opportunities to all applicants regardless of background.
Contact
Interested? Please send your CV and a very short cover letter to Alireza Kouchaki at alireza@oasi.care as soon as possible, but before September 15th, 2024. Applications will be evaluated on a rolling basis. For more information or questions please contact us via the email above or phone number +45 91809358.
