Manufacturing Quality Inspector

Job Description

Job Description

Salary :

Anteris 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. Help us build a team that will shape the future of TAVR.

We are seeking an experienced Quality Manufacturing Inspector to join our team in Maple Grove. As a Manufacturing Quality Inspector, you will play a critical role in the production of bovine tissue heart valves, ensuring the highest quality standards are met while maintaining strict adherence to safety and regulatory guidelines.

This position offers an exciting opportunity to contribute to the development of life-saving medical devices and work in a dynamic and collaborative environment.

Key Responsibilities :

• Quality Assurance : Maintain strict quality control measures by inspecting and verifying the integrity of sewn components, ensuring compliance with industry standards and company specifications.
• Primary work includes the inspection of in-process valves, and other products, to ensure they meet the procedure requirements.
• Verifies documentation meets both procedure and GDP requirements.
• Supports Receiving Inspection and downstream Final Product Inspection / test needs.
• Documentation : Complete and maintain accurate records of inspection activities, including results, nonconformance documentation, and batch record completion.
• Collaboration : Work closely with cross-functional teams, including engineers, quality control specialists, and production staff, to troubleshoot issues and optimize sewing processes to improve quality.
• Safety and Compliance : Follow all safety protocols and adhere to regulatory requirements, including FDA guidelines and ISO standards, to ensure a safe and compliant work environment.
• Training and Development : Assist in training and mentoring junior sewing staff to improve skills and maintain a high level of proficiency within the team.
• Continuous Improvement : Participate in process improvement initiatives to enhance efficiency, productivity, and product quality.
• All other duties as assigned

Required & Preferred Skills, Knowledge, Experience & Qualifications :

• High school diploma or equivalent; additional vocational or technical training in medical sewing is a plus.
• Minimum of 2 years' experience as an inspector in medical device manufacturing.
• Proficiency in using measurement tools such as, calipers, microscopes, visual aids and other measurement equipment, tappi chart, etc.
• Strong attention to detail and a commitment to maintaining the highest quality standards.
• Knowledge of FDA regulations and ISO standards related to medical device manufacturing is highly desirable.
• Excellent communication and teamwork skills.
• Ability to work independently and in a team-based environment.
• Strong problem-solving and troubleshooting skills.
• Heart valve and tissue inspection experience highly desired

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
17 days ago