JOB DETAILS
Quality Assurance Technician
CompanyArgen Corporation
LocationSan Diego
Work ModeOn Site
PostedJuly 7, 2026
About The Company
For over 60 years, Argen has stood as the dental industry’s most trusted partner, evolving from a small family business into a global leader serving laboratories in 105+ countries. What sets us apart isn’t just our scale, it’s our unwavering commitment to laboratory success and our unique position as a partners who support labs rather than compete with them.
About the Role
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
Key Skills
Quality AssuranceRegulatory DocumentationInternal AuditingRisk ManagementCAPA InvestigationsVerification and ValidationSOP CreationpFMEAISO 13485 ComplianceFDA QSR ComplianceDevice History RecordsTechnical WritingInterpersonal CommunicationTask PrioritizationMedical Device StandardsNPI Activities
Categories
ManufacturingEngineeringHealthcareScience & Research
Benefits
Health PlansDental PlansVision Plan401k With Employer MatchPaid Time OffPaid HolidaysEmployee EventsWellness ProgramsEmployee Discounts
Job Information
📋Core 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.
📋Job Type
full time
💰Salary Range
$24 - $28
📊Experience Level
2-5
💼Company Size
414
📊Visa Sponsorship
No
💼Language
English
🏢Working Hours
40 hours
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