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    Medical Device Quality Engineer I - Santa Clara, United States - Osteoid Inc

    Osteoid Inc
    Osteoid Inc Santa Clara, United States

    4 weeks ago

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    Description
    Job Description

    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.

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