Quality Control Inspector

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.

Primary Duties and 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.

Skills, Knowledge, Experience & Qualifications

Physical Requirements

• Ability to stand or sit for extended periods of time, often for the majority of the work shift.
• Ability to perform repetitive hand and finger movements requiring high levels of dexterity and precision.
• Ability to lift and move materials up to 25 pounds (or another weight appropriate for your environment).
• Ability to maintain steady hand control for delicate work involving small components or biological materials.
• Ability to work under magnification, including frequent use of microscopes or magnifying equipment for extended periods.
• Ability to visually inspect small components or tissue structures with a high degree of accuracy.
• Ability to maintain sustained focus on detailed tasks in a production or laboratory environment.
• Ability to perform visual and dimensional inspection of small components using microscopes and measurement tools.
• Ability to document inspection results accurately in quality systems or electronic records.
• Ability to maintain accuracy and consistency while performing repetitive tasks that require sustained focus and attention to detail.
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Work Environment

• Work is performed in a cleanroom and/or controlled laboratory environment.
• Employees must adhere to strict gowning procedures, which may include wearing gowns, gloves, masks, hair covers, and shoe covers.
• Must be able to work comfortably in a temperature- and humidity-controlled environment.
• May require handling biological materials, including treated animal tissue, in accordance with established safety and regulatory protocols.
• Must follow cGMP, ISO, and company quality system procedures at all times.
• Ability to work in a highly regulated medical device manufacturing environment with strict documentation and process controls.
• Ability to work independently with minimal supervision while consistently following established procedures, work instructions, and quality standards.

Required Skills and Knowledge:

• 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.

Preferred Skills and Knowledge:

• 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.

Compensation

Target base salary range: $22 - $28 /hr. Final compensation will be based on experience and alignment with role requirements.  Unfortunately, we are unable to sponsor work visas (OPT, H1B, etc.) at this time.

What We Offer:

• 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.

Note: We may require proof of COVID-19 vaccination to comply with health institutions, state, local municipality, and/or travel regulations.

Anteris Technologies recruits, employs, trains, compensates, and promotes regardless of race, religion, color, national origin, sex, disability, age, veteran status, and other protected status as required by applicable law. We have a clear vision: to be a place of belonging for all humans by promoting diversity, multiculturism and inclusion, as a goal and reflection across the organization. Diversity is more than a commitment - it is part of our mission to deliver the best structural heart products on a global scale.