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Join Our Transformative Team: Ensure Excellence in OTC Medical Device Quality and Compliance!
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Are you ready to take on a pivotal role that combines strategic oversight, analytical rigor, and global impact? We''re a small, innovative team revolutionizing the world of over-the-counter (OTC) medical devices that treat various ailments of the skin, throat, nose, and more. From inventing cutting-edge products to navigating complex global regulatory landscapes, we bring ideas to life and ensure they reach markets worldwide.
Were looking for a talented QA Manager with a passion for compliance, a knack for problem-solving, and a drive to make a difference. The position offers you the autonomy to govern the QMS, lead design transfer projects, understand and develop production requirements, and transform them into world-class self-care solutions.
What Youll Love About This Role:
Our Values:
At the heart of our company is a commitment to creating self-care products that truly make a difference. We believe in thinking beyond the ordinary, crafting solutions that set the global standard for performance and reliability.
What Drives Us:
Join us, and become part of a company where your ideas, expertise, and dedication will help redefine what self-care can be.
Bring Your Talents:
Were seeking someone with strong organizational skill, capable of coordinating diverse processes while ensuring compliance with our ISO- and MDR-certified eQMS. Were looking for talent in efficiently bringing various external sources of production and post-production information together, with meaningful conclusions toward the continuous improvement of the quality we bring to users and patients. If you thrive in a fast-paced environment and love translating ISO norms and regulatory requirements into real-world processes and applications, we want to meet you!
Core Tasks and Responsibilities:
Oversee and continuously improve the Quality Management System (QMS)
Ensure compliance with applicable regulations (EU MDR, ISO 13485) and international quality standards
Develop and maintain quality documentation, including SOPs, work instructions, and quality manuals
Collaborate with R&D teams to integrate quality considerations into product design and development processes
Manage and coordinate internal and external audits, including supplier audits
Manage and oversee the CAPA, Complaint Management, PMS and Vigilance processes
Review product risk management activities and help maintain risk documentation
Coordinate with CMOs to ensure adherence to quality standards in and Pronovas requirements of production
Coordinate Management Review and drive continuous improvement initiatives
Monitor and analyze quality metrics to identify trends and areas for improvement
Liaise with regulatory bodies and notified bodies as needed
Provide input to the Product Development Manager and the PRRC.
Job Requirements:
MSc degree in Pharmac