Argen

Quality Engineer ll

Monday – Friday, 8:30 am – 5:00 pm

About Us

At Argen, we’re in the business of creating healthy, confident smiles one case at a time. Argen is a global leader in dental manufacturing with headquarters in San Diego, CA, subsidiaries in Canada, Germany, UK, and China, and sales in 105 countries worldwide. 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 a product offering that spans fixed, removable, ortho, implants, and equipment. Our 140,000 square foot manufacturing center houses more than 150 3D printing and milling machines and operates six days a week. Argen’s products are held to the highest standards of quality, and are FDA 510(k) cleared, ISO 13485 certified, and MDSAP compliant. Argen embodies a culture of innovation, continuous improvement, and LEAN practices in support of our mission to help our dental laboratory customers succeed.

About the Opportunity

The Quality Engineer ll is responsible for supporting the dental material manufacturing process and designing improvement activities and quality improvement initiatives. 

In this role, the successful candidate will:

• Coordinates with quality and engineering personnel to assure compliance to internal policies and procedures as well as to applicable external standards (GMP, QSR, ISO 13485, MDR, etc.).
• Performs quality review and approval of regulated documentation including, but not limited to, part/component/system inspection reports, nonconforming material reports, deviations, engineering change orders, engineering change reports, and engineering work orders.
• Reviews and approves supplier documentation (protocols, reports, specifications, etc.), as defined in the Quality Agreement.
• Responsible for adherence to supplier and customer Quality Agreement provisions.
• Interfaces with customer on quality activities.
• Verifies, creates and/or revises SOPs, work instructions and associated forms, and participates in the implementation of these procedures.
• Verifies engineering tests and measurement practices for new and existing products using appropriate tools (FMEA, DOE, SPC, Risk analysis, Process Capability).
• Manages of the CAPA, Complaints, Non-Conforming Material, Deviation systems; including generating Quality metrics.
• Reviews and supports the generation of engineering specifications to assure that adequate quality assurance requirements are met.
• Reviews drawings for adherence to design inputs, design control procedures, regulatory standards and quality system requirements.
• Provides Quality oversight for Product Release and shipping activities.
• Provides quality guidance and support to other departments.
• Performs quality engineering activities for design changes to existing product designs by assisting engineering in the preparation of plans and DHF documentation.
• Assists manufacturing in NPI activities.
• Creates SOP’s and update exiting SOP’s.
• Assists in the preparation of regulatory submissions to the U. S. FDA and other regulatory agencies.
• Reviews and approves Device History Records for finished device release as required.
• Serves as a technical resource for technicians, assemblers, and other Argen personnel.
• Leads the development of adequate inspection criteria. 
• Identifies and qualifies equipment required to perform inspections.
• Supports the transfer of designs to contract manufacturers, including establishment of inspection plans at Argen and at the supplier.
• Establishes and implements systems to ensure timely quality inspections for incoming materials, components or finished goods products. 
• Works with engineering to develop adequate inspection criteria. 
• Performs inspections as needed, or ensures that inspections are performed by qualified personnel, and that inspection results and documentation support the recommended disposition action. 
• Develops quality plans. 
• Leads post market surveillance activities.
• Supports the analysis and presentation of information to executive management concerning measures of product and service quality, supplier performance, manufacturing problems and design issues as identified through various quality system elements. 
• 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 and 4+ years’ experience in medical device quality engineer related work or equivalent experience in quality system such as ISO 9001; or Master’s degree with 2+ years’ experience
• Demonstrated understanding of medical device design and process controls per FDA Quality System Requirements (QSRs)
• 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
• 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 learn technical concepts by reading work instructions and standard operating procedures, and completing on-the-job training.
• 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
• ASQ CQE certification 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