Quality Engineer ll
Location: San Diego, CA, US
Hours: Monday – Friday, 8:30 am – 5:00 pm
Salary Range: $115,000 To 130,000 Annually
This is an exciting opportunity for a Quality Engineer ll to join a growing, technology-focused and service-oriented team. If you 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, this position is perfect for you.
About Us
We are 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. We are a technology-based manufacturing organization focused on three key business segments, including dental alloys, zirconia, and digital dentistry solutions. We continue to invest in innovative product improvement initiatives through our Quality Management System to provide our global customers with affordable, high-performance products and industry-leading excellent service. Our products are FDA regulated and ISO certified.
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 otherArgenpersonnel.
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 Engineeringor an equivalent degree from an accredited institutionis required and4+ years' experience in medical device quality engineer related work or equivalent experience in quality system such as ISO 9001;orMaster's degreewith 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!
We offer exciting opportunities for training and learning, career development and advancement from only the best in the dental industry. With all that hard work, we are committed to ensuring the welfare of our 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
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