Argen Corporation · 3 months ago
Quality Systems Engineer
San Diego, CA
Full-time
Onsite
Senior Level
$80K/yr - $90K/yr
5+ years expArgen Corporation is focused on maintaining and improving quality management systems in compliance with regulatory requirements. The Quality Systems Engineer will lead and manage CAPAs, audits, and quality plans while fostering a culture of quality across the organization.
3D PrintingDentalManufacturing
Responsibilities
Ensures the Argen QMS complies with ISO13485, EU MDR, MDSAP, and U.S. Food and Drug Administration (FDA) regulations
Guides and maintains the CAPA process, including investigation, root cause analysis, corrective and preventive actions, and effectiveness verification, to drive continuous improvement and prevent recurrence of quality issues
Ensure timely closure and effectiveness verification of CAPAs
Monitor CAPA trends and report metrics to management
Plan, execute, and document internal audits to ensure compliance with quality standards, regulatory requirements, and QMS procedures
Coordinate and support external audits (e.g., FDA, Notified Bodies, customers)
Track and facilitate closure of audit findings and observations
Plans, organizes, and facilitates management review meetings to evaluate the effectiveness of the QMS, review quality metrics, discuss improvement opportunities, and ensure appropriate resource allocation
Develop and manage quality plans for new products, process changes, and improvement initiatives
Collaborate with cross-functional teams to ensure quality objectives are met
Track progress and report on quality plan milestones and outcomes
Analyzes quality data and metrics to identify trends, monitor performance, and drive improvement initiatives, providing regular reports to management
Fosters a culture of quality throughout the organization by promoting awareness, accountability, and continuous improvement in quality processes and practices
Supports and participates in product recall activities including documentation, activity management, tracking and trending analysis, and interface with government officials, when applicable
Motivates and develops employees by providing feedback, training opportunities, and holding regular 1:1s
Delegates tasks, monitors progress and ensures alignment with departmental goals
Builds a culture of collaboration and accountability while actively resolving team conflicts
Other duties as assigned
Qualification
Required
Bachelor's degree and a minimum of 5 years' experience in the medical device industry or equivalent combination of education, training, and experience
Strong knowledge of FDA QMSR, ISO 13485, EU MDR, MDSAP and other applicable standards
2 years auditing per ISO and/or FDA standards, including direct involvement with external regulatory audits
5 years' experience in managing CAPA processes, conducting investigations, performing root cause analysis, and implementing corrective and preventive actions
Internal Auditor Certification for ISO 13485 required
Demonstrated experience in planning and conducting internal and external audits
Excellent organizational and project management skills, with the ability to prioritize tasks, meet deadlines, and manage multiple projects simultaneously
Strong analytical and problem-solving skills, with the ability to analyze data, identify trends, and drive continuous improvement initiatives
Strong leadership and influencing skills, including the ability to set goals and follow through, build positive relationships
Team-oriented 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 learn technical concepts by reading work instructions and standard operating procedures and completing on-the-job training
Preferred
Lead Auditor Certification for ISO 13485 preferred but not needed
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
Company
Argen Corporation
The Argen Corporation is the world’s largest manufacturer of precious dental gold alloys, leader in zirconia manufacturing, and leading innovator of digital dentistry solutions and scrap refining services.
201-500 employees
H1B Sponsorship
Argen Corporation has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2023 (3)
Funding
Current Stage
Growth StageLeadership Team
Anton Woolf
CEO
Company data provided by crunchbase