Senior Quality Control Inspector

Anteris Tech•Maple Grove, MN

60d•Onsite

About The Position

Anteris is a science-driven structural heart company that is redefining expectations and advancing the field through cutting-edge solutions focused on restoring native-like physiology versus treating symptoms of structural heart disease. We are currently developing a new class of TAVR designed to mimic the performance of a healthy aortic valve. With offices in Minneapolis, MN, US; Geneva, Switzerland; and Brisbane and Perth, Australia, we have a growing and inclusive team. 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. The 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. 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.
5+ years’ overall experience in Medical Device (ISO 13485, FDA QSR) manufacturing environment.
5+ years’ 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.
Competitive compensation package, including salary, performance-based bonuses, and stock options.
Career development opportunities and a chance to be part of a growing company that values its employees.
Medical, Dental, and Vision Plans
Flexible Spending Account (FSA)
401k + Company Match
Life, AD&D, Short Term and Long-Term Disability Insurance
Bonus Plan Eligibility
Employee Equity Program
Paid Holidays & PTO
Employee Assistance Program
Inclusive Team Environment