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Job DescriptionJob DescriptionSalary: $160,000 - $190,000 + 15%
Anteris Technologies is a global structural heart company dedicated to revolutionizing cardiac care. With offices in Minneapolis, MN, US; Geneva, Switzerland; and Brisbane and Perth, Australia, we have a growing and inclusive team.
Our mission is to forge new frontiers in cardiac care by pioneering science-driven and measurable advancements to restore heart valve patients to healthy function. Transcatheter Aortic Valve Replacement (TAVR) technologies were originally designed for older, high-risk patients. Today, younger, more active patients need a better solution that will not just open and close but restore healthy heart function. We seek to restore healthy blood flow patterns by creating the worlds first biomimetic TAVR valve, DurAVR THV. This cutting-edge valve, incorporating our proprietary ADAPT anti-calcification technology, is designed to mimic the natural function of a healthy heart valve.
As the Senior Manager of Quality at Anteris, you will play a key leadership role in supporting our mission to deliver safe, effective, and high-performing medical devices. Reporting to the VP of Quality, you will manage day-to-day quality operations with an emphasis on Tissue and Valve Quality Manufacturing Engineering, Quality Control oversight, and routine Quality Management System activities. You will serve as process owner for Production Controls, ensuring product and process compliance across manufacturing operations and continuous improvement in support of commercialization readiness.
At Anteris Technologies, youll 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.
Key Responsibilities:
Operational Quality Leadership: Lead daily quality operations supporting tissue and valve manufacturing, ensuring adherence to internal and external quality standards.
Quality Control Oversight: Supervise the Quality Control team responsible for in-process, incoming, and final inspections, ensuring that all materials and finished goods meet specification requirements.
Production Controls Ownership: Act as process owner for production controls, ensuring appropriate documentation, validation, and change management for manufacturing processes and equipment.
Manufacturing Quality Engineering: Guide the Quality Manufacturing Engineering function supporting tissue processing, valve assembly, and related production activities; ensure robust process validation and control strategies.
Quality Management System (QMS): Maintain and continuously improve QMS processes including CAPA, nonconformance management, document control, and internal audits in partnership with the Quality Systems team.
Cross-Functional Collaboration: Partner with Operations, Engineering, Regulatory, and R&D teams to proactively address quality issues, support new product introductions, and implement sustainable process improvements.
Metrics and Reporting: Develop and monitor quality performance metrics (yield, defect trends, audit outcomes, etc.), using data to identify improvement opportunities and drive accountability.
Regulatory Compliance: Ensure all activities comply with applicable standards and regulations (FDA QSR, ISO 13485, EU MDR), maintaining readiness for audits and inspections.
Continuous Improvement: Promote Lean and Six Sigma principles within the quality organization to enhance efficiency and reduce variability in manufacturing processes.
Team Development: Mentor and develop quality professionals to build technical depth and a culture of ownership, integrity, and teamwork.
Skills, Knowledge, Experience & Qualifications
Bachelors degree in Engineering, Life Sciences, or related field; advanced degree .
Minimum 8 years of progressive quality experience in the medical device industry, with at least 3 years in a leadership or supervisory capacity.
Demonstrated experience supporting manufacturing quality operations, preferably with implantable Class III devices.
Strong knowledge of regulatory standards (FDA QSR, ISO 13485, ISO 14971, MDR).
Proven ability to manage Quality Control and Quality Engineering functions, including process validation and inspection oversight.
Experience maintaining and improving a QMS and leading audits.
Excellent analytical, communication, and collaboration skills.
Certification such as ASQ CQE, CQA, or Lean Six Sigma Green Belt is advantageous.
Experience with TAVR and tissue valve manufacturing a plus.
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 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 health institutions, state, local municipality, and/or travel regulations.
Anteris Technologies recruits, employs, trains, compensates, and promotes regardless of , , , , , , , 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 , multiculturism and , as a goal and reflection across the organization. is more than a commitment - it is part of our mission to deliver the best structural heart products on a global scale.
If you are interested in applying for this job please press the Apply Button and follow the application process. Energy Jobline wishes you the very best of luck in your next career move.
#J-18808-Ljbffr
We focus on the Oil & Gas, Renewables, Engineering, Power, and Nuclear markets as well as emerging technologies in EV, Battery, and Fusion. We are committed to ensuring that we offer the most exciting career opportunities from around the world for our jobseekers.
Job DescriptionJob DescriptionSalary: $160,000 - $190,000 + 15%
Anteris Technologies is a global structural heart company dedicated to revolutionizing cardiac care. With offices in Minneapolis, MN, US; Geneva, Switzerland; and Brisbane and Perth, Australia, we have a growing and inclusive team.
Our mission is to forge new frontiers in cardiac care by pioneering science-driven and measurable advancements to restore heart valve patients to healthy function. Transcatheter Aortic Valve Replacement (TAVR) technologies were originally designed for older, high-risk patients. Today, younger, more active patients need a better solution that will not just open and close but restore healthy heart function. We seek to restore healthy blood flow patterns by creating the worlds first biomimetic TAVR valve, DurAVR THV. This cutting-edge valve, incorporating our proprietary ADAPT anti-calcification technology, is designed to mimic the natural function of a healthy heart valve.
As the Senior Manager of Quality at Anteris, you will play a key leadership role in supporting our mission to deliver safe, effective, and high-performing medical devices. Reporting to the VP of Quality, you will manage day-to-day quality operations with an emphasis on Tissue and Valve Quality Manufacturing Engineering, Quality Control oversight, and routine Quality Management System activities. You will serve as process owner for Production Controls, ensuring product and process compliance across manufacturing operations and continuous improvement in support of commercialization readiness.
At Anteris Technologies, youll 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.
Key Responsibilities:
Operational Quality Leadership: Lead daily quality operations supporting tissue and valve manufacturing, ensuring adherence to internal and external quality standards.
Quality Control Oversight: Supervise the Quality Control team responsible for in-process, incoming, and final inspections, ensuring that all materials and finished goods meet specification requirements.
Production Controls Ownership: Act as process owner for production controls, ensuring appropriate documentation, validation, and change management for manufacturing processes and equipment.
Manufacturing Quality Engineering: Guide the Quality Manufacturing Engineering function supporting tissue processing, valve assembly, and related production activities; ensure robust process validation and control strategies.
Quality Management System (QMS): Maintain and continuously improve QMS processes including CAPA, nonconformance management, document control, and internal audits in partnership with the Quality Systems team.
Cross-Functional Collaboration: Partner with Operations, Engineering, Regulatory, and R&D teams to proactively address quality issues, support new product introductions, and implement sustainable process improvements.
Metrics and Reporting: Develop and monitor quality performance metrics (yield, defect trends, audit outcomes, etc.), using data to identify improvement opportunities and drive accountability.
Regulatory Compliance: Ensure all activities comply with applicable standards and regulations (FDA QSR, ISO 13485, EU MDR), maintaining readiness for audits and inspections.
Continuous Improvement: Promote Lean and Six Sigma principles within the quality organization to enhance efficiency and reduce variability in manufacturing processes.
Team Development: Mentor and develop quality professionals to build technical depth and a culture of ownership, integrity, and teamwork.
Skills, Knowledge, Experience & Qualifications
Bachelors degree in Engineering, Life Sciences, or related field; advanced degree .
Minimum 8 years of progressive quality experience in the medical device industry, with at least 3 years in a leadership or supervisory capacity.
Demonstrated experience supporting manufacturing quality operations, preferably with implantable Class III devices.
Strong knowledge of regulatory standards (FDA QSR, ISO 13485, ISO 14971, MDR).
Proven ability to manage Quality Control and Quality Engineering functions, including process validation and inspection oversight.
Experience maintaining and improving a QMS and leading audits.
Excellent analytical, communication, and collaboration skills.
Certification such as ASQ CQE, CQA, or Lean Six Sigma Green Belt is advantageous.
Experience with TAVR and tissue valve manufacturing a plus.
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 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 health institutions, state, local municipality, and/or travel regulations.
Anteris Technologies recruits, employs, trains, compensates, and promotes regardless of , , , , , , , 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 , multiculturism and , as a goal and reflection across the organization. is more than a commitment - it is part of our mission to deliver the best structural heart products on a global scale.
If you are interested in applying for this job please press the Apply Button and follow the application process. Energy Jobline wishes you the very best of luck in your next career move.
#J-18808-Ljbffr