QA Software Engineer, Sr.

Quality Assurance (Prismatik, a Glidewell Company) Irvine, California


Description

Position at Prismatik

Essential Functions:
  • Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
  • Partners with software development teams in Software Development Lifecycle (SDLC) documentation including software development plans, software verification and validation, software requirements specifications, software architecture and design documents, design and code reviews, software Risk Management File (RMF), test protocols and reports, traceability matrices.
  • Participates in Quality Management System (QMS) activities in compliance with US FDA Quality System Regulations and ISO 13485.
  • Participates in software risk management activities including cybersecurity risk by collaborating and providing feedback to software development teams.
  • Remains current on existing and new regulations to support compliance of existing software.
  • Utilizes knowledge and expertise guide development team in seeking solutions and alternatives to meet regulations.
  • Conducts testing and assesses the effectiveness and accuracy of software against existing operating standards or performance guidelines.
Minimum Qualifications:
  • Bachelor’s degree in Engineering, Biomedical, or related technical field; or any equivalent education and/or experience from which comparable knowledge, skills and abilities have been demonstrated/achieved.
  • Minimum eight (8) years of experience in quality engineering in the FDA QSR/ISO 13485 medical device industry.
  • Experience with the application of IEC 62304 (Medical Device Software Lifecycle Processes), ISO 14971 (Risk Management), IEC 60601 (Medical Electric Equipment) and IEC 62366 Usability Engineering, required.
  • Experience with Agile software development methodologies like Scrum and Kanban, required.
  • Experience with embedded software development areas, such as web development, required.
  • Previous experience with cloud-based software, preferred.
Pay range: $95,833-$130,000/yr
Exact compensation may vary based on skills and experience.

Glidewell Laboratories is the industry leader in dental technology due to our agility, speed, and cutting edge technology. We work in a fast-paced and highly sought-after employee-friendly work environment. Behind all of this success is an amazing group of people who are passionate about bringing innovation to the marketplace, while providing quality and affordability to better the lives of people all over the world. If you share in our passion for teamwork and a vision for excellence, let's talk about a rewarding career at Glidewell!

In addition are the following generous employee benefits: Medical, Dental, Vision, 401K with company match, company-paid life insurance, additional onsite dental services, vacation, holiday, and sick time, employee gym (with fitness classes and meditation room), employee medical/wellness center (with massage therapy and acupuncture), two company subsidized cafes, Internet cafes, employee lounges with big screen TVs, game tables, fun company sponsored events, a diverse work environment with over forty nationalities represented, and much more!

Glidewell Laboratories is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. We are committed to the principle of equal employment opportunity for all employees and to provide employees with a work environment free of discrimination and harassment on the basis of race, color, religion, national origin, sex, age, physical or mental disability, veteran status, sexual orientation, gender identity, genetic information, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at [email protected]. Please indicate the specifics of the assistance needed.

Note to Current employees: Please apply through Employee Transfer Application to complete the transfer request form.