Accuray Incorporated (Nasdaq: ARAY), based in Sunnyvale, Calif., is the premier radiation oncology company that develops, manufactures and sells personalized innovative treatment solutions that set the standard of care, with the aim of helping patients live longer, better lives. The Company’s leading edge technologies – the CyberKnife and TomoTherapy Systems – are designed to deliver radiosurgery, stereotactic body radiation therapy, intensity modulated radiation therapy, image guided radiation therapy, and adaptive radiation therapy. For more information, please visit www.accuray.com .
Accuray is looking for a Senior Quality Engineer to join our team in Madison, WI.
SUMMARY: Works in a Quality Systems environment to ensure that the design, development, manufacturing and support of medical devices meet the requirements of ISO 13485, 21 CFR Part 820, and other applicable regulations and standards. Supports all phases of product lifecycle, including New Product Development, On-going Production, Continuing Engineering, and Customer Complaints.
ESSENTIAL DUTIES AND RESPONSIBILITIES: The Senior Quality Engineer will represent Quality Assurance on product and process development teams as well as participate in development, review and approval of Quality and Manufacturing Plans. The Senior Quality Engineer will interact with suppliers on quality issues, perform supplier audits, and help establish appropriate quality controls as necessary with new suppliers. This role includes Quality ownership of Accuray product lines through the entire product lifecycle (customer requirements through design and validation to post commercialization and customer complaints). Other duties may be assigned on an individual basis:
- Represent Quality Assurance on New Product Development teams. Develop Quality Plans to identify new technologies, processes or suppliers requiring verification or validation.
- Oversee the development of Validation Master Plans during the technology transfer phase of new product development programs.
- Oversee the creation of process validation (IQ/OQ/PQ) protocols and reports.
- Participate on Risk Management teams.
- Review and approve design changes to existing products.
- Perform supplier qualifications, material issue resolution, drive supplier corrective actions, and manage approved supplier list.
- Perform internal Quality system audits.
- Administer incoming and in-process inspection program utilizing statistical techniques as appropriate.
- Administer the Calibration program.
- Administer the NCMR system and facilitate MRB meetings.
- Review production and QC records and perform product release of Accuray products.
- Assist CAPA investigators by providing guidance to drive to root cause analysis and practical corrective and preventive solutions.
- Provide training to Accuray employees on the proper use of Quality tools and procedures.
- Bachelor’s Degree in Engineering or other scientific discipline.
- 5+ years experience in Quality Assurance or Regulatory Affairs in the medical device industry.
- ASQ certification or equivalent highly desirable.
- Competency in the FDA Medical Device Quality System Regulations and ISO 13485.
- Strong oral and written communication skills .
- Experience in the manufacture of high voltage electrical systems, high power microwave devices and linear accelerators a plus.