Quality Engineer II

Anteris Technologies is seeking a Quality Engineer II to support the development, commercialization, and ongoing manufacturing of our delivery system. In this role, you will be a key contributor to ensuring manufacturing quality, process robustness, and regulatory compliance across our product platform. You will work cross-functionally with engineering, manufacturing, and quality teams to drive validation, risk management, and continuous improvement initiatives.

In this role, you will:

• Partner with R&D, Design, Process, and Manufacturing Engineering to develop and execute product and process validation strategies.
• Support delivery system manufacturing processes, including product quality activities.
• Participate in cross-functional mRB discussions and support nonconformance invesigations, including CAPAs and customer complaints.
• Develop sampling plans and approve inspection methods for in-process and finished product acceptance.
• Review and support execution of validation activities including IQ, OQ, PQ, TMV, and software validation
• Analyze product and process performance to identify failure modes, trends, and opportunities for improvement
• Support resolution of complex technical issues related to manufacturing processes
• Ensure compliance with applicable regulatory standards (e.g., FDA CFR 820, ISO 13485, ISO 14971) and support audit readiness and execution
• Maintain and assess effectiveness of CAPAs and quality system processes
• Contribute to risk management activities, including PFMEAs and process risk assessments
• Develop and maintain process monitoring and control strategies aligned to product and process risk
• Evaluate process variation and capability, driving continuous improvement initiatives where needed
• Support development and maintenance of quality documentation, including control plans, work instructions, and inspection methods
• Participate in internal and external audits and respond to audit observations as needed
• Conduct manufacturing process audits to ensure adherence to GMP, production controls, and quality standards

Basic Qualifications:

• Bachelor’s degree in Engineering, Physical Science, or related discipline
• 2+ years of manufacturing quality experience in a medical device company
• Experience supporting process validation, risk management, nonconformance handling, and process improvement in regulated environments
• Working knowledge of FDA CFR 820, ISO 13485, and ISO 14971
• Understanding of process controls, statistics, test method validation, and new product development processes
• Experience with product and process verification and validation activities
• Strong technical writing and documentation skills

Preferred Qualifications:

• Master’s degree in Engineering or related field
• Experience with Class III medical devices
• Experience with valve manufacturing or biological tissue products
• Familiarity with ISO 5840 standards
• Strong knowledge of inspection methods and measurement systems
• Experience with statistical tools, DOE, and process capability analysis
• Certifications such as ASQ CQE, Six Sigma, or CQA
• Experience with requirements management tools (e.g., Jama Connect)
• Demonstrated ability to solve complex problems and contribute in a fast-paced, cross-functional environment

Compensation:

Target base salary range: $88,000 – $108,000, plus eligibility for an annual short-term incentive (STI) targeted at 7% of base salary and equity participation. Final compensation will be determined based on experience and alignment with role requirements. Unfortunately, we are unable to sponsor work visas (OPT, H1B, etc.) at this time.

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. 

Our 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 Equity Program
• Paid Holidays
• Paid Vacation
• Employee Assistance Program
• Inclusive Team Environment