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Product Quality Specialist
2 weeks ago
Radiobotics is seeking a Product Quality Specialist to join our team. In this role, you will be responsible for ensuring the highest standards of product quality across our entire range of medical devices.
Your Key Responsibilities
- Work closely with cross-functional teams to drive product releases and ensure compliance with regulatory requirements.
- Develop and implement quality management systems to guarantee the efficient and effective delivery of products.
- Conduct risk analyses and identify areas for improvement in our existing products and manufacturing processes.
- Collaborate with management to prioritize regulatory approval activities and optimize market potential.
- Create and coordinate product submissions for our developed devices, possibly with consultant support.
- Train colleagues on QMS procedures and best practices.
- Participate in internal and external audits to ensure adherence to industry standards.
What We're Looking For
- A minimum of 1 year's experience in quality assurance and/or regulatory affairs.
- Excellent communication and interpersonal skills, with the ability to lead cross-functional projects.
- Knowledge of quality management systems and regulatory requirements within MDR and ISO 13485, with experience in Software as a Medical Device a plus.
Why Radiobotics?
- A dynamic and supportive work environment with opportunities for professional growth.
- A commitment to integrity, transparency, and innovation.
- A competitive compensation package and comprehensive benefits.
