Quality Assurance Engineer

Company: Kyocera Medical Technologies, Inc.
Location: Redlands
Posted on: May 7, 2022

Job Description:

Job DescriptionSalary: Kyocera Medical Technologies, Inc. (KMTI) is looking for a Quality Assurance Engineer in our Redlands, CA facility. KMTI is committed to providing innovative products that help surgeons meet demanding patient needs. By combining advanced technologies with tried-and-true design principles, KMTI aims to enhance device performance and longevity. KMTI is a leader in re-inventing the medical implant industry. Our offices are located in Redlands, California and Austin, Texas. We are focused on innovation with the highest level of quality and technology.We offer an excellent benefits package which includes Medical, Dental, Vision, generous PTO and 401(k) with company match.Position Summary:This position will provide leadership in the execution of various Quality System functions, such as Finished Device Acceptance, Management of Nonconforming Product, Corrective/Preventive Action, Complaint Handling, and Supplier Management per FDA and ISO requirements. Additionally, candidate will work with a cross-functional team in the design and development of orthopedic medical devices, including active participation in Design Control, Risk Management, and Design Transfer tasks.

Required Work Experience and Technical Competencies:Candidates must have a minimum of 2 years work experience. Required technical competencies include:

• Working understanding of typical quality control (QC) methodologies and equipment within a manufacturing environment.
• Represent quality engineering on the New Product Development (NPD) projects, including with the identification of user needs/design requirements, the creation of product specifications, participation in design reviews, the approval of design verification and validation activities, and the transfer of the design into production. Also, must have the capacity to audit the complete NPD process.
• Ability to facilitate change control process for technical documentation, including product specifications and test protocols/reports, ensuring regulatory requirements and operational goals are met.
• Aptitude to provide technical support for the QC inspection process.Required Educational and Academic Competencies:
  • Bachelor of Science Degree in Biomedical, Mechanical, Manufacturing, Industrial Engineering or equivalent.
  • Familiarity with FDA Quality System Regulations (QSR)/Good Manufacturing Practices (GMP), ISO 13485, or similar regulatory framework.
  • Knowledge of common statistical tools and root cause analysis techniques.
  • Strong competence with MS Office products.
  • Working understanding of GD&T.Kyocera Medical Technologies, Inc. values diversity in its workforce, and is proud to be an AAP/EEO employer. All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Kyocera Medical Technologies, Inc.'s Human Resources team directly at 909-557-2360.

Keywords: Kyocera Medical Technologies, Inc., Redlands , Quality Assurance Engineer, Engineering , Redlands, California