Quality Assurance Supervisor

Argen Corporation • San Diego, CA

2d

About The Position

Argen Corporation currently has an exciting opportunity for a Quality Assurance Supervisor to join a growing, technology-focused and service-oriented team. If you are passionate about sourcing and securing highly qualified talent at all levels of the organization, thrive in a fast- paced and dynamic environment, and want 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.

In this role, the successful candidate will:

Works directly with quality assurance manager, quality engineer and Project Manager to ensure all inspection requirements are properly identified.
Works directly with Production personnel to ensure that inspections are scheduled and performed as required.
Trains Quality Control Inspectors (QCI) on proper inspection techniques and utilization of measuring devices.
Conducts internal audits/surveillance to ensure adherence to company procedures/policy in the areas of quality, safety and training.
Confers with management and engineering staff to determine quality and reliability standards.
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.
Manages proactively by holding regular 1:1s and team meetings to ensure open lines of communication and professional development for direct reports.
Selects product for testing at specific stages in the installation process, and tests product for variety of qualities such as dimensions, performance, and mechanical or electrical characteristics.
Develops, modifies, applies, and maintains quality standards for processing materials into partially finished or finished material or product.
Devises and implements methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment.
Designs or specifies inspection and testing mechanisms and equipment, conducts quality assurance tests, and performs statistical analysis to assess the cost of products or materials that do not meet required standards and specifications.
Recommends modifications to existing quality or production standards to achieve optimum quality within limits of equipment capability.
Sets up and performs destructive and non-destructive tests on materials, parts, or products to measure performance, life, or material characteristics.
Organizes materials for presentation and participates in management reviews.
Tracks and monitors CAPA and NCMRs
Assists in the preparation of regulatory submissions to the U.S. FDA and other regulatory agencies.
Performs training activities for new hires and existing employees in compliance with the training procedure.
Other duties as assigned.

Requirements

• Bachelor’s degree and two years of technical experience or Associate’s degree and five years of technical experience required, or equivalent combination of education and experience.
• Two or four year degree in Engineering, Quality or a related field.
• 1-3 years of people management experience.
• Experience with inspection, test, troubleshooting.
• Attention to detail.
• 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.
• Strong verbal and written communication skills.
• Ability to understand and follow site protocols, policies and procedures.

Nice To Haves

• Digital dental lab supervisory experience preferred.
• Team leadership experience preferred.

Responsibilities

• Works directly with quality assurance manager, quality engineer and Project Manager to ensure all inspection requirements are properly identified.
• Works directly with Production personnel to ensure that inspections are scheduled and performed as required.
• Trains Quality Control Inspectors (QCI) on proper inspection techniques and utilization of measuring devices.
• Conducts internal audits/surveillance to ensure adherence to company procedures/policy in the areas of quality, safety and training.
• Confers with management and engineering staff to determine quality and reliability standards.
• 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.
• Manages proactively by holding regular 1:1s and team meetings to ensure open lines of communication and professional development for direct reports.
• Selects product for testing at specific stages in the installation process, and tests product for variety of qualities such as dimensions, performance, and mechanical or electrical characteristics.
• Develops, modifies, applies, and maintains quality standards for processing materials into partially finished or finished material or product.
• Devises and implements methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment.
• Designs or specifies inspection and testing mechanisms and equipment, conducts quality assurance tests, and performs statistical analysis to assess the cost of products or materials that do not meet required standards and specifications.
• Recommends modifications to existing quality or production standards to achieve optimum quality within limits of equipment capability.
• Sets up and performs destructive and non-destructive tests on materials, parts, or products to measure performance, life, or material characteristics.
• Organizes materials for presentation and participates in management reviews.
• Tracks and monitors CAPA and NCMRs
• Assists in the preparation of regulatory submissions to the U.S. FDA and other regulatory agencies.
• Performs training activities for new hires and existing employees in compliance with the training procedure.
• Other duties as assigned.

Benefits

• Medical, dental and vision Plans
• 401k with Employer Match
• PTO
• 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: Manager