Quality Assurance Specialist for Medical Devices
vor 21 Stunden
Innovative, fast-growing start-ups in the pediatric care sector are transforming young patients' lives with Class III medical devices.
We're looking for a Quality Assurance Specialist to join our team.
This role is perfect for someone who thrives in a dynamic environment and is passionate about quality management.
Key responsibilities:
- Develop and implement quality procedures for design and manufacturing processes.
- Manage risk assessments and ensure compliance with regulatory requirements.
- Lead product testing and batch release activities.
- Collaborate with suppliers to maintain high-quality standards.
To succeed in this role, you'll need:
- A Master's degree in Mechanics, Biomedical Engineering, or a related field.
- 5+ years of experience in quality management, preferably in the medical device industry.
- Expertise in ISO 13485 and MDR 2017/745 standards.
- Excellent analytical skills and attention to detail.
- Ability to work independently and as part of a team.
We offer a competitive salary range of $80,000 - $100,000 per year, commensurate with experience.
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