Quality Assurance Engineer
Quality Assurance Engineer
This is the opportunity to create a bright future and career in an environment where YOU are valued.
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Come join our team.
The position is responsible for developing, maintaining, and improving the quality systems in accordance with the requirements of ISO, FDA, QSR, and Argen policies. This would include, but is not limited to: Quality Planning in support of new product development, product quality improvement, compliant and CAPA management, supplier quality management, production and process controls, and continuous improvement through the use of statistical techniques and other accepted quality practices. This position plans and directs activities concerned with development, implementation, maintenance, and continuous improvement of our quality system.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Develop, document & validate inspection and test methods to support in-process and final inspection activities.
- Ensures compliance to applicable regulatory standards and internal procedures
- Supports design and development activities for new product development, including regulatory submissions.
- Leads and documents design verification, validation , and risk management activities
- Perform quality engineering development activities for new product designs by assisting Engineering in the preparation of design and development plans, Design History File documentation, and Design History File preparation.
- Perform ongoing quality engineering activities on current products to improve product designs and/or manufacturing processes including participation in NCM, Complaint, and CAPA investigations and actions as necessary.
- Participate in Hazard Assessment, Failure Mode and Effect Analysis, and risk management analysis, as required, for new and current products.
- Participate in external safety test agency testing and preparation of Risk Management file and checklists.
- Participate in usability engineering and assist engineering with the creation of usability engineering file documents.
- engineering in the preparation of plans and DHF documentation.
- Perform an IEC 62304 audits for software development activities.
- Assist in the preparation of regulatory submissions to the U. S. FDA and other regulatory agencies.
- Review and approve Device History Records for finished device release as required.
- Serve as a technical resource for technicians, assemblers, and other Argen personnel.
TECHNICAL COMPETENCIES (Knowledge, Skills & Abilities)
- Demonstrated understanding of medical device design and process controls per FDA Quality System Requirements (QSRs) and ISO 13485
- 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 prioritize and execute tasks in a timely manner without direct supervision
EDUCATION AND EXPERIENCE
- A 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
- Intimate knowledge of PFM, Crown and Bridge applications and their use in the dental lab.
- ASQ CQE certification is a plus
PHYSICAL REQUIREMENTS / WORK ENVIRONMENT (if applicable)
- Ability to lift up to 25 pounds on occasion
Who We Are:
Argen is the world leader in the manufacturing of dental alloys and an industry front-runner in digital dental manufacturing, offering more than 600 precious and non-precious alloys to more than 100 countries. We are a well-established and growing family-owned business in a prosperous industry, dedicated to improving people's lives through innovative services and products we create. Our team maintains the highest levels of integrity and we are dedicated to our core values. We are poised for incredible growth, building on five decades of exceptional products and services.
VEVRAA Federal Contractor
This job description indicates in general terms, the type and level of work performed as well as the typical responsibilities of employees in this classification and it may be changed by management at any time. Other duties may also apply. Nothing in this job description changes the at-will employment relationship existing between the Company and its employees. Distribution of this item outside of the Company without an authorized release is a violation of Company policy.
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