Quality Control Inspector - I, II, Sr.

Anteris Tech•Maple Grove, MN

8d•Onsite

About The Position

Anteris is a science-driven structural heart company focused on restoring native-like physiology. We are developing a new class of TAVR designed to mimic the performance of a healthy aortic valve. The Quality Control Inspection team supports manufacturing operations, ensuring products conform to specifications and are evaluated for compliance with visual, dimensional, functional, and other requirements. This role is responsible for performing inspections in a highly regulated medical device development and manufacturing environment across various areas including 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.

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.
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.
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.
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.

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 in strict compliance with the Anteris Quality Management System including Good Documentation Practices.
Perform 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

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