Quality Control Inspector - Maple Grove, MN

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 ...

Job description

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.

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

Required Skills and Knowledge:

• High School diploma or equivalent.
• 4+ years' overall experience in Medical Device (ISO 13485, FDA QSR) manufacturing environment.
• 2+ 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.

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.

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.
• 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.

Health and Wellness Offerings:

• 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

Note: We may require proof of COVID-19 vaccination to comply with the 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.

Pay: $ $31.00 per hour

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Paid time off
• Referral program
• Vision insurance

Application Question(s):

• Are you willing to work the 6am - 2pm shift?

Education:

• High school or equivalent (Required)

Experience:

• medical device quality inspection: 1 year (Preferred)

Ability to Commute:

• Maple Grove, MN Preferred)

Work Location: In person