Quality Specialist

Location

Santa Clara, CA | United States

Job description

Who is Anatomage?

Founded in 2004, Anatomage is a world-leading health care technology company. Anatomage offers 3D medical imaging software and hardware for diagnosis, treatment planning, customized surgical devices, and anatomy education in both the dental and medical industries. Anatomage is a pioneering medical technology company at the forefront of innovation, specializing in creating cutting-edge educational solutions. With a focus on revolutionizing the field of medical and dental education, Anatomage is dedicated to providing educators and learners with state-of-the-art tools and resources.

About the Role:

We are looking for a Quality Specialist to join our rapidly expanding team. As a member of our Quality and Regulatory team, you will be responsible for developing and maintaining our quality system for our medical device products. Together as a team, you will help to ensure our products are safe and follow global quality standards. 

*This is an on-site position and will require reporting to our headquarters location in Santa Clara, CA.*

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 the 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:

• Proficiency in computer technology and operations 
• Ability to work independently and as part of a team 
• Demonstrate attention to detail 

Preferred Qualifications:

• Experience with Medical Device Software and Hardware 
• Experience with QMS/eQMS 
• Knowledge of ISO 13485
• Global regulatory affairs experience (FDA, MDD/CE/MDR, UKCA, etc.) 
• Document Control experience 
• 2+ years of experience in a quality engineering quality specialist, quality assurance or similar role 
• ASQ certification preferred 

Benefits

Minimum Education and Experience Required:

• Bachelor's degree in scientific, engineering or related field 

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
• Collaborative and inclusive work environment

Anatomage is an Equal Employment Opportunity employer. We do not offer H1B Sponsorship at this time. Local candidates preferred.

About Anatomage 

Anatomage has been financially robust and growing for 18 consecutive years. Doctors world-wide have enthusiastically responded to the company’s products, making us a market leader and setting the industry standard. Currently, thousands of clinics and hospitals use Anatomage's software for patient diagnosis and treatment planning. Leading radiology equipment companies use Anatomage’s software as a key component in their systems.

Anatomage offers the world’s first and only life-sized virtual dissection table. Students can learn anatomy and physiology using highly interactive and accurate real human-based digital data. Institutions can offer high quality education without worrying about chemicals, facility costs, and regulatory issues. Hundreds of schools have adopted the Anatomage Table as the main teaching tool for students.

At Anatomage, there is an opportunity to work alongside the best in the field. With a diverse group of people from various technical, clinical, and artistic backgrounds, Anatomage provides a culture where distinguished individuals can work and collaborate in an organic manner. Our team members all bring unique strengths and talents to their group and embrace each other's diverse perspectives. Anatomage offers a distinct work experience with an exceptional opportunity to develop careers. Our philosophy is to foster a dynamic work environment, and we are proud to let our employees' knowledge and responsibilities grow with the company.

Fraud Recruitment Disclaimer 

It has come to our notice that fraudulent and fictitious job opportunities are being circulated on the Internet. Prospective candidates are being contacted by certain individuals, mainly through telephone calls, emails and correspondences, claiming they are representatives, subsidiaries or under contract with Anatomage, Inc., and, thus, pretending to represent Anatomage. The main purpose of these correspondences and announcements is to obtain privileged information from individuals, or to induce people to pay a fee for services related to recruitment or training or a new role.

Anatomage Does Not:

• Send job offers from free email services like Gmail, Yahoo mail, Hotmail, etc.;
• Request payment of any kind from prospective candidates for employment or any sort of fees;
• Authorize anyone to either collect money or arrive at any monetary arrangement in return for a job at Anatomage; and
• Request or require personal documents like bank account details, tax forms or credit card information as part of the recruitment process.

Legitimate emails from @ anatomage.com domains are from the organization, anything outside of the stated domain is likely a scam and fraudulent email. If you have received an offer from any domain other than @ anatomage.com, it is likely a scam and not a legitimate offer. Please do not provide any personal information to the imposters posing as recruiters or the HR manager of Anatomage, Inc. We recommend blocking and reporting their accounts for unauthorized and fraudulent behaviors.

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Salary