What are the responsibilities and job description for the Quality Engineering Technician position at Artivion?
Company Overview
Headquartered in suburban Atlanta, Georgia, Artivion, Inc. specializes in developing innovative medical devices aimed at addressing challenging cardiac and vascular conditions. Our Austin facility houses a diverse team dedicated to producing the On-X Mechanical Heart Valves. With over 1,600 employees globally and manufacturing sites in Atlanta, Austin, and Hechingen, Germany, Artivion serves healthcare professionals in over 100 countries. For more details on the On-X Mechanical Heart Valve, click here.
Position Objective:
The Quality Engineering Technician is responsible for supporting the day-to-day operations of the manufacturing floor by ensuring that products meet strict quality standards. This role involves monitoring and supporting the production process, identifying non-conformance issues, and implementing corrective actions to ensure product integrity. The technician plays a critical role in maintaining compliance with regulatory standards and contributing to the overall quality management system (QMS) within the medical device manufacturing environment.
Responsibilities:
- Support the development and maintenance of quality documentation, including work instructions and test protocols.
- Ensure that manufacturing processes and documentation meet applicable regulatory and quality system requirements.
- Participate in the development and review of process procedures and quality assurance practices.
- Perform routine review GDP review of logbooks, processing records, and other documentation on the manufacturing floor.
- Support engineering activities including process and equipment validations.
- Perform complaint investigations, including sample evaluations and DHR reviews.
- Plan, prepare, and execute calibrations and analyze data to approve equipment and processes used in the testing, processing, storing, and distribution of products.
- Author Quality metric reports, as required.
- Identify and report product deviations, defects, or discrepancies during production.
- Investigate root causes of non-conformance issues and work with cross-functional teams to implement corrective and preventive actions.
- Support the implementation of changes to processes or products to mitigate defects and improve quality.
- Work closely with production staff to identify opportunities for process improvements, ensuring high-quality production and waste reduction.
- Collaborate with maintenance, quality, operations, and engineering teams to sustain and improve on key performance indicators.
- Assist with internal and external audits, ensuring adherence to quality standards and regulations.
- Provide training on quality procedures and best practices.
- Perform environmental monitoring of ISO 7/ISO 8 cleanroom environment.
- Offer guidance and support to resolve technical quality issues on the floor.
Other responsibilities as assigned.
Qualifications:
- Minimum of a Bachelor’s Degree in Engineering, Quality, Manufacturing, or related field, or equivalent experience.
- 0-2 years’ experience, preferably in an FDA regulatory industry (i.e., pharmaceutical, biomedical, medical device field) with an in-depth knowledge of current Good Manufacturing Practices, Quality System Regulations, and ISO Standards.
Equal Employment Opportunity Employer (EEO):
We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected status under applicable law.
