Quality Compliance Specialist

As the Quality Compliance Specialist, you will be responsible for overseeing and ensuring the effectiveness and compliance to ensure the organization adheres to all quality standards, regulatory requirements, and industry best practices. Your expertise in corrective and preventive actions (CAPA), quality plans, audits, and management reviews will be instrumental in maintaining compliance with

regulatory requirements and driving continuous improvement initiatives. Your strong leadership and communication skills will enable you to collaborate with cross-functional teams and drive a culture of quality throughout the organization.

Schedule: M-F, 8:30 AM - 5:00 PM

Location: 5855 Oberlin Dr. San Diego, CA 92121

The day-to-day:

• Ensures the Argen QMS complies with EU MDR, MDSAP, and U.S. Food and Drug Administration (FDA) regulations.
• Oversees and maintains the CAPA process, including investigation, root cause analysis, corrective actions, and effectiveness verification, to drive continuous improvement and prevent recurrence of quality issues.
• Manages the Quality Plans created in the company, monitors their compliance and ensure they are closed in a timely manner.
• Develops, implements, and maintains an effective quality management system (QMS) in compliance with relevant regulatory requirements, standards (e.g., ISO 9001), and industry best practices.
• Supports and provides input to corporate management review activities including MDR, CAPAs.
• Coordinates internal audits to assess compliance with quality standards, regulatory requirements, and QMS procedures, following up nonconformances detected during internal and external audits.
• Manages the internal audit process for non-conformances identified and ensures corrections and corrective actions are implemented in a timely manner.
• Support during external audits conducted by a notified body or any regulatory entity
• 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.
• 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 coaches employees by assessing employee performance and providing helpful feedback and training opportunities.
• Delegates tasks and manages progress to ensure successful completion of department objectives.
• Creates and reinforces a culture of teamwork and actively resolves conflicts within the team.
• Strong leadership and team management skills, with the ability to inspire and motivate a diverse workforce.

What does it take to be successful:

• Bachelor degree and a minimum of 5 years' experience in the medical device industry or equivalent combination of education, training, and experience.
• 2 years auditing per ISO and/or FDA standards, including direct involvement with external regulatory audits.
• 5-7 years of people management experience.
• ASQ CQE certification is a plus but not needed.
• Lead Auditor Certification for ISO 13485 preferred but not needed.
• Knowledge of the following regulation areas as they pertain to quality systems and product recall processes: QSR, ISO, EU MDR, MDSAP.
• Experience in managing CAPA processes, conducting investigations, performing root cause analysis, and implementing corrective and preventive actions.
• 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)

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.