Quality Control Manager

The Quality Manager will lead the quality team and the quality process for SprintRay 3D printing resins. The role will develop a site quality process that meets ISO 9000, ISO13485:2016, FDA cGMP 21 CFR 820 regulations and other regulatory requirements. This position will work very closely with our R&D, production, and product management teams to define our customers quality requirements and ensure our ability to meet or exceed these requirements. The role will build and manage the quality team as the directing supervisor. 

Responsibilities:

• Maintain complete ownership over the Resin Quality Management Systems
• Design and maintain an ISO Certified Quality Management Program
• This position creates and manages processes, training, standards, and goals to deliver quality results 
• Maintain ISO 13485, FDA and other Quality Standards. Maintain accurate documentation at all times during the manufacturing and inspection process per Good Manufacturing Practices.
• Measure, report, and react on all site quality metrics including supplier quality, internal quality, and customer complaints. 
• Develop SPC and SQC capabilities to enable predictive mitigation on product quality.
• Perform testing and inspection at various stages of production, including visual and dimensional inspection 
• Establish, implement or develop testing methods to measure all critical resin quality
• Parameters. 
• Maintain and monitor equipment to ensure proper operation as well as perform complete Device History Record review including inspection documentation
• Set annual quality goals and build and execute programs to accomplish the goals
• Lead quality investigations 
• Lead and coach all site employees regarding customer stakeholder expectations
• Development of people (training) and implementation of quality programs
• Prepare and lead the site through customer visits / audits 
• Conduct internal quality audits 
• Conduct site training for quality 

Qualifications:

• Must be at least 18 years of age 
• Must be legally authorized to work in country of employment without needing sponsorship for employment visa status now or in the future 
• Must have a four-year Bachelor's degree from an accredited institution or eight years of work experience 

Preferred Requirements:

• Must have at least three years experience in R&D, Product Development, Quality Control or Operations
• Prior experience in a quality function at a chemical, materials or medical manufacturing facility
• Must have the ability to see color with or without reasonable accommodation
• Must have excellent grasp of root cause failure analysis tools (fish bone, 5-why analysis, etc)
• Proven record of protecting others’ well-being and inspiring them to comply with safe operating procedures 
• Demonstrated leadership with a focus on organizational performance alignment, and building a culture of trust & integrity 
•  Proven customer service, decision making, and high impact communication
• Established record of creating action plans for self and others to complete work efficiently and on time 
• Lean manufacturing knowledge an asset 
• Effective communication and strong interpersonal skills 
• Must have ability to drive for results and ability to influence
• Ability to prioritize and manage multiple tasks and issues and meet commitments
• Ability to work from Glendale, CA and Huntington Beach, CA location
• Prior knowledge and understanding of ISO 13485, MDSAP, and FDA QSR compliance

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.

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 is an equal opportunity employer.

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