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SprintRay

Quality Assurance Manager

Westminster    Full Time    R&D Materials   

At SprintRay, we are in a super-charged growth mode, and are constantly looking for ways to maintain the quality of our products and processes while growing at a phenomenal pace. To help grow and maintain this quality standard, we are seeking a Quality Assurance (QA) manger to provide QA support and leadership to ensure compliance with ISO 13485, MDSAP, and FDA QSR for all products, implement, maintain, and lead the Company’s Quality Management System, conduct internal audits and qualify vendors and, follow regulatory guidance to ensure standards and requirements are consistently met. 

The Quality Assurance Manager leads, develops, implements, and executes quality assurance strategy that assures the Company has effective systems to meet all applicable regulations and standards. In this position, you will lead a team of associates who maintain Quality Management Systems including the Complaints function, Internal and External Audits, Training, and Document Control.

Job Duties and Responsibilities:

  • Ensures the QMS is fully implemented and meets requirements of relevant regulations and reviews and updates procedures to remain in compliance. Including assessment and update of tools that support the QMS and site wide QMS training.
  • Oversight of quality system requirements, acceptance activities, document controls, training, internal and external audits, and complaint handling to ensure regulatory compliance and efficient control systems.
  • Provide data, trending, and detailed analysis to support internal daily management.
  • Work with SprintRay to develop and implement global procedures.
  • Collaborate with external regulatory agencies regarding audit site visits for dental products manufactured and sold in the United States and abroad.
  • Keep updated knowledge of standards, regulatory requirements, and directives applicable for Medical Devices and ensure updating relevant parts of the QMS.
  • Apply SprintRay concepts and tools in the performance of daily activities.
  • Lead cross-functionally to ensure adequate temporary & permanent countermeasures are put in place in a timely manner, and sustained, to address the appropriate customer complaints

Key Qualifications

  • Bachelor’s degree, preferred in Sciences or Engineering field.
  • Min 3 years of proven experience in medical device quality assurance.
  • Detailed knowledge of CFR 21 Part 820, ISO 13485, and related quality standards
  • Previous supervisory experience

 

About SprintRay

SprintRay is a forward-thinking, nimble company on a journey to provide digital dentistry solutions to our customers. Since 2014 we have produced products that are advanced, user-friendly, and offer a premium experience. Our organization is customer-centric, high-performing, and globally diverse. Challenging assumptions by identifying and solving problems is our way of life. We leverage conventional and unconventional wisdom with an entrepreneurial spirit that leaves no stone unturned as we develop the highest quality products, services, and relationships. For us to stamp our name on a product, it must be carefully considered, targeted, and meticulously designed to solve our customers’ most pressing problems and pave the way for the future. We work to continuously redefine the rules for our industry through our passion for technology, innovation, and our community. We have bold ambition and work to stay connected to what’s happening on the front lines of our business so that the needs of our customers are always being met.

 

Our Core Philosophy

  • Customers Come First: We place customers at the center of everything we do by producing products they love and hold in high regard.
  • Better Together: We are collaborative; our potential is unlocked when we frequently communicate with clarity, respect, and transparency.
  • Empowered Talent: We are inspired by our people and work to empower and reward their meaningful contributions.
  • Nurturing Environment: We create a sustainable work environment, which is essential to the balanced well-being of our employees.
  • Solution Driven: We believe every issue has a solution which is why we come to the table with a pragmatic, problem-solving mindset.
  • Highly Adaptive: We have an agile mindset. When conditions change, we adjust our focus and continue pushing forward.
  • Committed: We act with integrity and recognize the importance of keeping individual and collective commitments.
  • Diverse and Open Minded: We value and respect global diversity by always being open to hear new options, field new ideas, and bring fresh perspectives to the table.
  • A Family: We have fun, enjoy the journey, and celebrate success as a teams.

To All Recruitment Agencies:

SprintRay does not accept agency resumes. Please do not forward resumes to company email addresses or other company contacts. SprintRay is not responsible for any fees related to unsolicited resumes. Unsolicited resumes received will be considered our property and will be processed accordingly.

 

SprintRay Inc. is an equal opportunity employer.