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Medical Device Quality Engineer I

4 months ago

Santa Clara, United States Anatomage Full time
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. www.osteoidinc.com.

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'll be 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.