Medical Device Quality Engineer I

Job Description

Salary: $75,000 to $78,000

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!

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.

Osteoid is an Equal Employment Opportunity Employer. We do not offer H-1B Sponsorships at this time. Local candidates preferred.