Medical Device Quality Engineer I

Who is Osteoid?
Osteoid is creating the next generation of seamless and connected 3D dental imaging software and solutions that help accelerate the path to digital dentistry. Proven in over ten years of use by thousands of labs and dental practices, Osteoid’s software and hardware tools keep dental practices and labs ahead of the curve and allow dentists to competently diagnose any patient scan in 3D. An osteoid is a soft organic element that forms bones in the human body. Just like osteoids in the human body, Osteoid is providing the essential software to dental practice success. Osteoid is a wholly owned dental-focused subsidiary of Anatomage. .
About the Role
We are looking for a Quality Engineer or Specialist to join our rapidly expanding team. As a member of our Quality &
Regulatory team, you’llbe responsible for developing and maintaining our quality system for our medical device products. Together as a team, you’ll help ensure our products are safe and follow global quality standards.
This position is based in Santa Clara, California.
What You’ll Do
Help manage, implement, maintain, and improve the quality management system for our medical device products.
Provide support and guidance for introducing and maintaining medical devices in global markets, which may include duties like documentation, auditing support, risk analysis, complaint investigation and handling, CAPA, regulatory submissions, post-market surveillance, and more.
Work together with other departments to provide a holistic approach to product development
Requirements
Skills and Abilities Required
Strong analytical and problem-solving skills
Previous success working in a fast-paced, dynamic and creative environment
Excellent verbal and written communication skills.
Self-motivated individual who thrives on doing a job well and has the initiative and drive to excel
Ability to effectively prioritize, organize, and perform a variety of concurrent tasks
Team player attitude, eager to be part of an ambitious team
Great interpersonal skills
Qualities We Look For
Experience with Medical Device Software and Hardware
Experience with QMS/eQMS
Knowledge of ISO 13485 / MDSAP
Global regulatory affairs experience (FDA, MDD/CE/MDR, UKCA, etc.)
Document Control experience
Proficiency in computer technology and operations
Ability to work independently and as a team
Demonstrate attention to detail
Minimum Education and Experience Required
Degree in scientific, engineering, or related fields.
2+ years of experience in a quality engineering, quality specialist, quality assurance, or similar role.
ASQ certification preferred
Benefits
What We Offer
Health, Dental, and Vision care for you and your family
401K savings plan with employer matching
Generous PTO leave and paid holidays
Casual work culture
Gym Stipend
Employee Assistance Plan
Team bonding activities and more!
Osteoid is an Equal Employment Opportunity Employer. We do not offer H-1B Sponsorships at this time. Local candidates preferred.