Quality Assurance and Regulatory Affairs Expert
2 weeks ago
Company Overview:
SprintRay Inc. is a dynamic organization committed to innovation and excellence in the field of 3D printing technology. We foster a collaborative environment where talented individuals can explore creative solutions to complex challenges.
Position Summary:
We are currently seeking a dedicated Regulatory Affairs and Quality Assurance Specialist to enhance our regulatory compliance and quality management efforts. This role is essential in ensuring that our products meet the stringent standards set by regulatory bodies.
Key Responsibilities:
- Provide expert support in regulatory affairs and quality assurance to ensure adherence to ISO 13485, MDSAP, and FDA QSR for all products.
- Develop, implement, and sustain the Company’s Quality Management System.
- Stay informed about evolving regulations affecting medical device manufacturing.
- Assist the regulatory affairs team with submissions and documentation.
Qualifications:
- Minimum of 3 years of experience in regulatory compliance and quality assurance.
- Proven experience in the medical device sector.
- Familiarity with the implementation of Quality Management Systems.
- Strong understanding of ISO 13485, MDSAP, and FDA QSR compliance.
- Bachelor’s degree in Chemical or Biomedical Engineering or a related discipline.
- Highly organized with a keen attention to detail.
- Excellent communication skills, both written and verbal, in English.
- Ability to work collaboratively as part of a team while also being capable of independent work.
Compensation:
The salary range for this position is $78,000 to $142,560, with actual compensation determined by various factors including geographic location, skills, education, experience, and organizational needs.
Join Us:
If you are a proactive problem solver looking to make a significant impact in the field of 3D printing, we invite you to explore opportunities with SprintRay Inc. Together, we can shape the future of manufacturing and empower the next generation of innovators.
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Los Angeles, California, United States SprintRay Inc. Full timeCompany Overview:SprintRay Inc. is a dynamic organization committed to innovation and excellence in the realm of 3D printing technology. We foster a collaborative environment where creative minds come together to tackle complex challenges.Position Summary:We are currently in search of a dedicated Regulatory Affairs and Quality Assurance Specialist to join...
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