Director of Quality

    • San Diego, CA

Director of Quality

Argen Corporation currently has an exciting opportunity for a Director of Quality to join a growing, technology-focused and service-oriented team. Do you thrive in a fast- paced and dynamic environment? If you would like to be a part of an organization with an unwavering commitment to quality dental solutions, then explore our career opportunities and get to know Argen.

About Us
Argen is a family-owned and privately held company based in San Diego, CA with a state-of-the-art manufacturing center that provides high quality dental solutions to dental labs of all sizes. Founded as a precious metals company in South Africa, Argen has evolved into a dynamic, technology-based manufacturing organization focused on three key business segments, including dental alloys, zirconia, and digital dentistry solutions. Argen continues to invest in innovative product improvement initiatives through its Quality Management System to provide our global customers with affordable, high-performance products and industry-leading excellent service. Argen's products are FDA regulated and ISO certified.

In this role, the successful candidate will be:
•Responsible for Quality Assurance and Regulatory Affairs to ensure global product registration and compliance objectives are met. Collaborates and provides guidance to R&D, marketing, quality and other functional groups on RA/QA matters and provides leadership for global regulatory approval processes. This individual will ensure design control requirements are implemented and followed, will support multiple product development projects and will ensure that the quality objectives are met during the product development and design transfer life cycle.
•Leads the development of global regulatory strategies for Argen product development and sustaining projects.
•Works with cross-functional teams to explore regulatory pathways, assess and communicate key activities and associated risks.
•Ensures preparation of U.S. FDA 510(k) and global regulatory submissions for new and current products as required. Ensures that all submissions are accurate, completed in a timely manner and meet Argen standards.
•Knows and understands the regulatory environment in which Argen operates (Medical Device Components) and ensures that Argen's quality system complies with regulatory and quality requirements including ISO 9001 & 13485.
•Develops and executes new product development quality strategies and establishes product performance goals for the quality organization.
•Develops post market surveillance quality plans and measure results. Drives appropriate change based on the results.
•Ensures effective execution of the quality engineering activities in support of new product development, sustaining engineering projects and when applicable supplier changes.
•Continuously improves quality processes and quality systems with the goal of improving patient outcomes, reducing risk, maintaining regulatory compliance, and improving product quality/reliability.
•Ensures customer quality and quality business systems are fully implemented and operated effectively and consistently across sites.
•Leads the relationship with customer and external auditors on quality and regulatory compliance issues.
•Reviews product labeling and marketing materials to ensure compliance with regulatory requirements.
•Provides guidance, interpretation, and opinions on changing worldwide regulations, while maintaining active involvement in medical device and regulatory affairs organizations to ensure up-to-date knowledge of current and future industry trends.
•Develops and communicates a compelling regulatory strategy and mission. Provides subject matter leadership, training and vision to the regulatory team.
•Ensures all direct reports maintain training records that comply with applicable quality system requirements.
•Manages the annual operations budget for the regulatory affairs department.
•Applies and mentors/coaches the application of technical principles, theories, concepts and quality tools to complex systems and process
•Assesses the skills and competencies of department regulatory professionals. Recruits, develops and retains regulatory professionals who demonstrate exceptional performance.
•Other duties as assigned

What does it take to be successful?
•10 or more years' experience in a medical device (preferred) or pharmaceutical company.
•Minimum of 8-10 years of Regulatory Affairs supervisory experience.
•Strong knowledge of FDA, EU, Health Canada and other applicable international regulatory requirements including clinical trial requirements, quality system requirements, submission requirements, labeling and promotion requirements.
•Excellent organizational, computing and verbal/written communication skills.
•Strategic and analytical skills.
•Project management leadership experience.
•Strong critical thinking and decision-making skills.
•Ability to work well independently or within a cross-functional team environment.
•Knowledge of cGMP regulations ISO 13485, 21CFR Part 820, CMDR SOR/9

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/Dental/Vision Plans
401k with Employer Match
Paid Vacation, Holiday and Sick Time
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

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