Quality Assurance Technician at Argen Corporation

San Diego, California, United States -

Full Time

Start Date

Immediate

Expiry Date

05 Oct, 26

Salary

28.0

Posted On

07 Jul, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, Regulatory Documentation, Internal Auditing, Risk Management, CAPA Investigations, Verification and Validation, SOP Creation, pFMEA, ISO 13485 Compliance, FDA QSR Compliance, Device History Records, Technical Writing, Interpersonal Communication, Task Prioritization, Medical Device Standards, NPI Activities

Industry

Medical Equipment Manufacturing

Description

Monday – Friday, 7:00 am - 3:30 pm About the Opportunity Maintains and improves the quality systems in accordance with the requirements of MDSAP, ISO, FDA, QSR, and Argen policies. Executes activities concerned with development, implementation, maintenance, and continuous improvement of Argen’s quality system. In this role, the successful candidate will: * Aids in the preparation of regulatory documentation for domestic and international product registrations and secures appropriate regulatory documentation including device licenses, device listings, permits, and import/export certificates. * Ensures compliance to applicable regulatory standards and internal procedures. * Supports design and development activities for new product development, including regulatory submissions. * Test Method Documents (TMs, TM Validation Protocols, TM Validation Reports) pFMEAs. * Performs ongoing quality activities on current products to improve product designs and/or manufacturing processes including participation in NCM, Complaint, and CAPA investigations, supplier activities and actions as necessary. * Assists in maintenance and improvement of the Quality System with guidance of QA Management, including internal audits, external audits, and quality improvement activities. * Assists Engineering in the preparation and execution of verification and validation protocols and verification and validation test reports for new products and changes to current products. * Participates in Hazard Assessment, Failure Mode and Effect Analysis, and risk management analysis, as required, for new and current products. * Plans and participates in internal and external audits as required. * Aids in the evaluation of customer complaints for regulatory compliance and adherence to product claims. * Assists in manufacturing NPI activities. * Creates SOP’s and update exiting SOP’s. * Reviews and approves Device History Records for finished device release as required. * Serves as a technical resource for technicians, assemblers, and other Argen personnel. * Other duties as assigned. What does it take to be successful? * Bachelor’s degree in Quality Engineering, Quality Assurance, Biomedical Engineering or an equivalent degree from an accredited institution is required or equivalent experience in quality system such as ISO 13485, 21CFR820 * Preferred working knowledge of ISO 13485, 21CFR Part 820, CMDR SOR/98-282, 93/42/EEC, RDC 16 2013, MHLW MO 169 and TG(MD)R Sch3. * Demonstrated understanding of required standards / regulations impacting medical devices * Team-oriented professional with good interpersonal skills who is hands-on with a high energy approach to work * Ability to communicate ideas and information clearly, effectively, and frequently (verbal and written) · Ability to prioritize and execute tasks in a timely manner without direct supervision * Knowledge of PFM, Crown and Bridge applications and their use in the dental lab is a plus Our Awesome Benefits! Working for a growing innovative company like Argen means exciting opportunities for training and learning, career development and advancement from only the best in the dental industry. With all that hard work, Argen is committed to ensuring the welfare of its employees and provides an amazing benefit package that includes: * Health Plans * Dental Plans * Vision Plan * 401k with Employer Match * Paid Time Off and Paid Holidays * Employee Events * Wellness Programs * Discounts for home, travel, entertainment, relaxation that includes Mobile phone service, Technology, Airline and Hotel, Theater/Theme Park tickets, Restaurants and so much more! EOE/M/F/Vet/Disabled VEVRAA Federal Contractor

Responsibilities

Maintains and improves quality systems in accordance with MDSAP, ISO, and FDA requirements. Executes activities related to regulatory documentation, product validation, and continuous improvement of manufacturing processes.