QC Inspection Group Lead

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 Inspection Group Lead will be responsible for developing, training, and managing the performance of the QC Inspectors team at the Maple Grove site and work closely with leads in operations to properly prioritize, plan, and organize the teams on an on-going basis. This is a high visibility role with daily interactions across a wide range of peer groups in the Maple Grove site.

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.

·         Perform all duties listed below in strict compliance with the Anteris Human Resources policies.

·         Directly support the performance management process for QC Inspectors including on-going documentation of employee’s performance to standards/goals, development plan updates and actions, and routine performance reviews with each member of the team.

·         Directly support training and development for QC Inspectors across all areas of standard work (receiving inspection, first article inspections, label verifications, valve inspections, tissue inspections, pre-sterile product inspections, and sterile product inspections) within the team. Ensure cross training is planned and implemented for all members of the team and time off requests are supported and properly planned.

·         Maintain organization and order in QC Inspection areas and continually improve the use of visual factory standards in the QC Inspection work areas.

·         Ensure QC Inspection areas continually strive to align to Lean 5S principles during all phases of the QC Inspectors’ workday.

·         Collaborate with peers in Operations to effectively plan work, organize teams, and communicate issues in a timely manner.

·         Other tasks as assigned by manager or delegate.

Skills, Knowledge, Experience & Qualifications

Required Skills and Knowledge:

·         High School diploma or equivalent.

·         5+ years of overall experience in Medical Device (ISO 13485, FDA QSR) manufacturing environment.

·         2+ years’ work experience directly applicable to Primary Duties and Responsibilities listed above.

·         2+ years’ experience performing microscope inspection of visual product features in a manufacturing environment.

·         Ability to work in an ISO Class 7 or 8 cleanroom environment.

·         Experience working directly with computers to input data, perform receiving operations, complete training, and manage email communications.

·         Experience in the use of databases and statistics for analysis, data entry, and quality control.

·         Experience in reading and interpreting engineering drawings and specifications.

·         Experience being a team member on a cross functional and cross trained team.

·         Effective verbal and written communication.

·         Ability to work in a fast-paced environment.

·         Proficient in use of Microsoft Office suite of business applications (Word, Excel, PowerPoint, Outlook)

Preferred Skills and Knowledge:

·         Direct experience in assembly of hand sewn fabric and biological tissue based medical device products.

·         Direct experience in microscope inspection of hand sewn fabric and biological tissue based medical products.

·         Certified Lean Practitioner.

·         Professional training in Visual Management & 5S principles.

·         Professional training in team leadership.

·         Vocational or technical training in biological tissue sewing.

·         Experience working in Grand Avenue eQMS software.

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 Stock Option Plan

·         Paid Holidays & Vacation

·         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.