Quality Control Inspector

Anteris Technologies • Maple Grove, MN

4d • Onsite

About The Position

Anteris® Technologies is a global structural heart company dedicated to revolutionizing cardiac care. With offices in Minneapolis, MN, US; Geneva, Switzerland; and Brisbane and Perth, Australia, we have a growing and inclusive team. Our mission is to forge new frontiers in cardiac care by pioneering science-driven and measurable advancements to restore heart valve patients to healthy function. Transcatheter Aortic Valve Replacement (TAVR) technologies were originally designed for older, high-risk patients. Today, younger, more active patients need a better solution that will not just open and close but restore healthy heart function. We seek to restore healthy blood flow patterns by creating the world’s first biomimetic TAVR valve, DurAVR® THV. This cutting-edge valve, incorporating our proprietary ADAPT® anti-calcification technology, is designed to mimic the natural function of a healthy heart valve. The Quality Control Inspection team plays a key role supporting our manufacturing operations at the Maple Grove site. This role is involved in a wide range of inspection tasks, where the primary goal is to assure that the products we produce are conforming to specifications and properly evaluated for compliance to visual, dimensional, functional, and various other specified requirements. We are seeking a QC Inspector will be responsible for performing inspections in a highly regulated medical device development and manufacturing environment across all areas of standard work for the team (receiving inspection, first article inspections, label verifications, valve inspections, tissue inspections, pre-sterile product inspections, and sterile product inspections). This is a high visibility role with daily interactions across a wide range of peer groups in the Maple Grove site. Shift: Day Shift, Monday through Friday, 6:00 a.m. - 2:00 p.m. Note: This role could be filled at the Inspector I, II, or Senior level, depending on the candidate's experience & background. At Anteris Technologies, you'll be part of a team dedicated to enhancing the quality of life for patients with aortic stenosis through groundbreaking medical devices. Join us in our mission to revolutionize structural heart solutions.

Requirements

• High School diploma or equivalent.
• 2+ years’ overall experience in Medical Device (ISO 13485, FDA QSR) manufacturing environment.
• 1+ year's equivalent work experience directly applicable to Primary Duties and Responsibilities listed above.
• Strong attention to detail and experience in reading, interpreting, and comprehending product requirement documents and specifications.
• Experience in learning and cross-training on widening set of responsibilities in a team-based environment.
• Experience working directly with computers to input data, perform electronic based work tasks, complete training, and manage email communications.
• Effective verbal and written communication
• Ability to work in a fast-paced environment.
• Effective problem-solving and troubleshooting skills.

Nice To Haves

• Vocational or technical training in assembly, sewing, or inspection of biological tissue based medical devices.
• Vocational or technical training in the use of microscopes, including the use of specialized reticles and/or tappi charts.
• Vocational or technical training in the use of MicroVu optical inspection systems.
• Vocational or technical training in Lean or 5S principles.
• Vocational or technical training in GD&T principles and specification designs.

Responsibilities

• Perform all duties listed below in strict compliance with the Anteris Quality Management System including Good Documentation Practices.
• Responsible for performing receiving inspection on material / products supplied to Anteris to ensure conformance to requirements and specifications.
• Perform microscope and other aided visual inspections on biological tissue based medical device products to ensure conformance to processing requirements and specifications.
• Perform machine / software-controlled inspections on products to ensure conformance to processing requirements and specifications.
• Perform inspections, as required by procedure, in support of first article inspections and label verifications.
• Perform physical and visual inspections on material, products, and/or packaging being processed for sterilization.
• Make an informed decision, based on training to tasks assigned, on the acceptance of materials, products, and inspected features, requirements, and specifications in all standard work tasks.
• Complete and maintain accurate records of inspection activities, including measurements, observations, results, conclusions, nonconformance issues, and full completion of quality record fields in support of standard work tasks.
• Collaborate with peers in Operations to effectively stay on plan, be mutually organized to goals, and communicate effectively through escalation channels as required.
• Other tasks assigned by group lead or designee.

Benefits

• Opportunity to make a significant impact on the healthcare industry by advancing groundbreaking therapies.
• Collaborative and dynamic work environment with a culture of innovation and excellence.
• The chance to be part of a growing company that values its employees.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED