Proton Beam Therapy has become a reality to thousands of cancer survivors and is expanding around the world. In addition to its clinical value, the Proton Beam Treatment System is an effective platform for international research programs requiring high-energy particle physics capabilities. Optivus Proton Therapy, Inc. is a manufacturer of proton beam treatment centers with corporate head quarters located in Southern California. If you are looking for an excellent opportunity in a positive environment, we welcome your resume.
Optivus is currently looking for an individual to join our team of professionals and assist us with our mission of saving lives through Proton Beam Therapy, using their skills and experience as a Quality Assurance Manager. This position has the option of a flexible schedule with part-time, hybrid, or remote work possibilities.
The QA Manager works with teams and personnel to maintain the suitability and effectiveness of the Quality System. Performs trend analysis of Quality system operations and summarizes the results for management review.
Primary Duties:
- Identify the national (and international) medical device manufacturer regulations and safety standards affecting company operations and products. Work within the organization’s self-directed and project teams to develop appropriate policies and operating procedures for compliance. Update the policies and procedures as necessary for regulatory changes and observed trends.
- Regularly review the quality system performance for suitability and effectiveness. Report trends for periodic management reviews.
- Manage the internal audit program.
- Manage the Material and Product Inspection program
- Coordinate 510(k) creation and submission to the FDA for new and modified medical devices.
- Manage the Quality system training program for new employees, internal auditors, production and inspection personnel. In addition, coordinate refresher training for quality system changes.
- Manage the Corrective and Preventive Action program
Qualifications:
- BA/BS degree, plus coursework/advanced degree in business or quality systems
- Minimum three years of experience managing an ISO 13485 (or equivalent) quality system for a medical device manufacturer.
- Strong people skills, excellent oral and written communication skills, MS Office Suite (Word, Excel, PowerPoint).
- Team building and group problem solving experience.
- Training experience/Train the Trainer in ISO/QSR quality system concepts.
- An understanding of dimensional measurement, and tool/gage calibration principles. An understanding of statistical techniques and their application.
Education and Experience:
Bachelors Degree (BA/BS) or equivalent from a four-year college or technical school, an advanced degree in business or quality systems, and a minimum of three years experience managing quality systems/quality assurance in a medical device manufacturing environment.
Job Types: Full-time, Part-time
Pay: From $40.00 per hour
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Employee assistance program
- Flexible schedule
- Flexible spending account
- Health insurance
- Life insurance
- Paid time off
- Referral program
- Vision insurance
Schedule:
- 8 hour shift
- Monday to Friday
Application Question(s):
- What is your desired salary?
Experience:
- ISO 9001: 1 year (Required)
- Quality Assurance Managers: 1 year (Required)
Work Location: In person