Software Quality Engineer
Monday-Friday
Argen Corporation currently has an exciting opportunity for a Software Quality Engineer 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.
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About the Opportunity
Responsible for all aspects of assessing and validating Argen's software, including writing validation documents, executing test plans, and documenting and testing in an expedient manner.
In this role, the successful candidate will:
- Assesses new software applications and determines their impact on Quality, including assessing 21 CFR Part 11 compliance.
- Works closely with application owners to gather information about software, asks strategic
- Questions to determine the software's impact to Quality and develops a strong understanding of the software.
- Learns the scope and impact of the Company's Standard Operating Procedures, Work Instructions, and other documentation, specifically as it affects Quality.
- Creates software validation documentation packages from scratch, including specifications (URS, FS, DS) and qualifications documents (IQ, OQ, PQ), in accordance with our Quality system.
- Executes test validation protocols against software in various environments to ensure software is compliant
- Executes software change control documentation and testing to keep software compliant.
- Completes projects in a timely manner in a fast-paced, agile environment
- Other duties as assigned.
- Four-year degree in Computer Science or Engineering field, or comparable experience.
- 4+ years' experience in a similar or directly compatible position, with extensive documentation preparation, testing and execution, in a Quality-impacting field.
- 4+ years' experience in software quality engineering and testing in a medical device industry.
- Experience writing test plans and test reports, and planning and writing effective test cases.
- Extensive understanding of regulatory agencies and their impact on Quality, including FDA, ISO, HIPAA, MDSAP, MDR, and others as they become applicable to Argen.
- Ability to apply compliance rules and protocols to documentation in an effective manner.
- Solid understanding of and experience with different types of testing methods, such as functional, system, integration, UI, usability, and others.
- Proven communication skills with development and operations/support teams (written/oral).
- Highly motivated with strong technical and analytical skills.
- Able to work independently and take direction.
- Experience with intended use validation of non-product software applications (IUV).
- Experience testing B2B E-Commerce Site.
- Experience with or understanding of Argen's ERP, QAD.
- Ability to learn technical concepts by reading work instructions and standard operating procedures, and completing on-the-job training.
- Ability to learn technical concepts by reading work instructions and standard operating procedures, and completing on-the-job training.
- 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.
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!