ABOUT US:

AuST Manufacturing is a rapidly growing medical device design house and manufacturing facility, with an innovative and energetic team committed to improving patient outcomes through high-quality products and cutting-edge technology. We are committed to maintaining the highest standards of quality and compliance in all our operations.

JOB SUMMARY:

We are seeking a detail-oriented and dedicated Quality Engineering Technician to join our team. In this role, you will be responsible for ensuring that our medical devices meet the highest standards of quality and safety. You will conduct inspections, perform tests, and support the implementation of product, process, and quality system improvements to comply with regulatory standards such as FDA and ISO.

QUALIFICATIONS:

• Associate degree in Engineering, Quality Assurance, or a related field.
• 2+ years of experience in quality control, quality engineering, or quality assurance, preferably in the medical device industry.
• Working knowledge of GMP practices and regulations.
• Excellent attention to detail and problem-solving skills.
• Proficient in using quality control tools and software.
• Strong communication and documentation skills.
• Ability to work independently and as part of a team.

PREFERRED QUALIFICATIONS:

• Bachelor’s degree in Engineering or a related field.
• Certification in Quality Control (e.g., CQE, CQT).
• Experience with statistical analysis and quality improvement methodologies.

• Perform quality control inspections and functional tests on medical devices to ensure they meet required standards.
• Coordinate product builds as needed to support Quality Engineering projects.
• Maintain accurate and detailed documentation of quality control tests and inspections.
• Perform data entry into Excel and Minitab, for purposes of KPI monitoring, production scrap, and projects.
• Identify and report any quality issues or deviations from standards.
• Assist in the development and implementation of quality improvement strategies.
• Ensure compliance with regulatory standards such as FDA and ISO.
• Coordinate purchase, installation, and calibration, and documentation for test and inspection equipment.
• Participate in the review of engineering designs to contribute quality requirements and considerations.
• Assist in the development and implementation of quality control training programs.
• Review and update standard operating procedures, manufacturing instructions, or quality inspection documents.