Manufacturing Quality Inspector

Anteris Technologies is a structural heart company delivering clinically superior solutions that help healthcare professionals create life-changing outcomes for patients. We are currently developing the first-in-class biomimetic TAVR valve as a growing and inclusive medtech team with global office locations in Minneapolis, MN, US; Geneva, Switzerland; and Brisbane and Perth, Australia.

We are seeking an experienced Manufacturing Quality Inspector to join our team in Maple Grove, MN. The Quality Inspector is a key role in ensuring product quality throughout the manufacturing process.  Quality Assurance activities will focus on three key areas: incoming components, in-process, and finished product.  This role will also be involved with receiving and shipping components and products.  This person will work closely with the Quality engineering and Operations teams.

Shift: Monday to Friday

Hours:  7:00 AM to 3:30 PM with the flexibility to start at 6:00 AM during training period.

Location:  This is an onsite role in Maple Grove, MN

Primary Duties and Responsibilities:

• Complete component receiving transactions in the MRP system, along with shipping transactions for components, and finished goods.
• Perform incoming receiving inspection of medical device components using hand tools, fixtures, gages, stereoscopes, and optical measurement systems.
• Request, file, and save appropriate inspections records within the QMS
• Support the transfer of new product development projects from development to production. This will include completing First Article Inspections, data analysis and development of new measuring methods.
• Perform test method validations, GR&Rs, and develop inspection methods.
• Work with the Operations team to perform in-process and finished product inspections.
• Support nonconformance process
• Support internal and external audits – including preparation and direct interaction with auditors.

Required Skills & Knowledge:

• High school diploma / GED required; 2-year technical degree is a plus
• Strong knowledge of inspection methods in design, fabrication, and production of mechanical components
• Ability to understand mechanical drawings
• Demonstrated skill in the use of test and measuring equipment
• Medical device experience
• Ability to work in an ISO Class 8 cleanroom
• Ability to work with computers to input data, perform receiving operations, complete training, and manage email communications
• Ability to work as part of a cross functional team
• Effective verbal and written communication
• Ability to work in a fast-paced environment

Preferred Skills and Knowledge:

• Experience in the use of statistics for data analysis and quality control
• Experience with biological tissue
• Experience with geometric tolerancing inspections
• Experience with Grand Avenue eQMS software, or similar
• Experience with MRP system usage
• Experience programming MicroVu or similar measurement systems

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 Offerings
• 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.