Quality Assurance Technician

Argen Corporation • San Diego, CA

37d • Onsite

About The Position

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.

Requirements

• 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
• 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

Nice To Haves

• 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.
• Knowledge of PFM, Crown and Bridge applications and their use in the dental lab is a plus

Responsibilities

• 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.
• 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.

Benefits

• 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!

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level