Quality Engineer I

Argen Corporation
401(k)
United States, California, San Diego
Feb 19, 2025
The Quality Engineer I position supports the Quality Management System, designs improvement and activities, analyzes manufacturing processes to improve and maintain Quality standards of all Argen products. Schedule: M-F, 8:30 AM - 5:00 PM Location: 5855 Oberlin Dr. San Diego, CA 92121 The day-to-day: Coordinates with quality and engineering personnel to assure compliance to internal policies and procedures as well as to applicable external standards (GMP, QSR, ISO 13485, MDR, etc.). Performs quality review and approval of regulated documentation including, but not limited to, part/component/system inspection reports, nonconforming material reports, deviations, engineering change orders, engineering change reports, and engineering work orders. Reviews and approves supplier documentation (protocols, reports, specifications, etc.), as defined in the Quality Agreement. Responsible for adherence to supplier and customer Quality Agreement provisions. Interfaces with customer on quality activities. Verifies, creates and/or revises SOPs, work instructions and associated forms, and participates in the implementation of these procedures. Verifies engineering tests and measurement practices for new and existing products using appropriate tools (FMEA, DOE, SPC, Risk analysis, Process Capability). Manages the CAPA, Complaints, Non-Conforming Material, Deviation systems; including generating Quality metrics. Reviews and supports the generation of engineering specifications to assure that adequate quality assurance requirements are met. Reviews drawings for adherence to design inputs, design control procedures, regulatory standards and quality system requirements. Provides Quality oversight for Product Release and shipping activities. Provides quality guidance and support to other departments. Performs quality engineering activities for design changes to existing product designs by assisting engineering in the preparation of plans and DHF documentation. Assists manufacturing in NPI activities. Creates SOP's and update exiting SOP's. Assists in the preparation of regulatory submissions to the U. S. FDA and other regulatory agencies. Reviews and approves Device History Records for finished device release as required. Serves as a technical resource for technicians, assemblers, and other Argen personnel What does it take to be successful: Successful Supplier Management (SCARs, Evaluations, scorecards) Calibration ( prior experience in maintaining or supporting calibration activities). Validation (IQ, OQ, PQ). Bachelor's degree in Quality Engineering, Quality Assurance, Biomedical Engineering or an equivalent degree from an accredited institution is required and 1-2 years' experience in medical device quality engineer related work or equivalent experience in quality system such as ISO 9001; or Master's degree with 1+ years' experience Other Important Qualifications: Demonstrated understanding of medical device design and process controls per FDA Quality System Requirements (QSRs) Knowledge of cGMP regulations ISO 13485, 21CFR Part 820, CMDR SOR/98-282, 93/42/EEC, RDC 16 2013, MHLW MO 169 and TG(MD)R Sch3 preferred Demonstrated understanding of required standards / regulations impacting medical devices Knowledge of PFM, Crown and Bridge applications and their use in the dental lab is a plus ASQ CQE certification is a plus Our Awesome Benefits! Medical, dental and vision Plans 401k with Employer Match PTO Employee Events Wellness Programs Discounts for home, travel, entertainment and relaxation! About Us At Argen, we're in the business of creating healthy, confident smiles one case at a time. We are 500 team members strong. Founded more than 50 years ago as a precious metals company in South Africa, Argen has grown to become the largest dental zirconia manufacturer in North America, largest dental alloy provider worldwide, and leader in digital dentistry solutions with diverse product offerings. Our 140,000 square foot manufacturing center houses more than 150 3D printing and milling machines and operates six days a week. Argen embodies a culture of innovation, continuous improvement, and LEAN practices in support of our mission to help our dental laboratory customers succeed.