Quality Engineer III

At Baylis Medical Technologies, we develop innovative medical devices that improve patient care and enhance lives around the world. Quality is at the core of everything we do.

As a Quality Engineer III, you will play an important role in ensuring our products meet the highest standards of quality, safety, and regulatory compliance throughout the product lifecycle. This is a fully proficient engineering role where you will independently manage quality engineering activities, contribute to complex projects, and partner with cross-functional teams to solve technical and quality challenges.

Working closely with R&D, Manufacturing, Regulatory Affairs, Operations, Supply Chain, and external partners, you will provide quality engineering with a primary focus on day-to-day manufacturing and product support, continuous improvement projects, and design changes, and help ensure products and processes continue to meet applicable quality, safety, and regulatory requirements.

• Independently manage quality engineering activities and deliverables supporting manufacturing, validation, and lifecycle management initiatives.
• Provide quality engineering support for design and engineering changes by assessing quality and regulatory impact, updating risk and quality documentation, and confirming appropriate verification or validation activities.
• Own or support nonconformance reports (NCRs), including containment, investigation, root cause analysis, risk evaluation, disposition, implementation of corrective actions, and effectiveness follow‑up.
• Lead and support continuous improvement projects by analyzing quality and process data, identifying opportunities, evaluating risk, and implementing sustainable improvements
• Review and approve applicable Quality Management System documents and quality records within the role's area of expertise.
• Plan and prioritize assigned work independently, participate in project‑level planning, and provide technical guidance to cross‑functional engineers and stakeholders at all levels, as appropriate.
• Support continuous improvement projects by analyzing quality and process data, identifying opportunities, evaluating risk, and implementing sustainable improvements.
• Develop and execute verification and validation protocols, including data analysis, statistical rationale, sample size justification, and documentation.
• Participate in and lead investigations using structured problem‑solving methodologies such as 5 Why, Fishbone, and Fault Tree Analysis.
• Identify quality and compliance gaps and contribute to corrective and preventive actions that improve product and process performance.
• Analyze quality data and trends to identify improvement opportunities and reduce risk.
• Conduct supplier audits and internal audits, and participate in customer and regulatory audits, including audit preparation, documentation review, execution, and follow‑up activities.
• Partner with suppliers and internal stakeholders to address quality concerns and drive continuous improvement.
• Support method validation, equipment qualification, process validation, and manufacturing quality initiatives.
• Contribute to a culture of accountability, continuous improvement, and operational excellence.

• Bachelor's degree in Engineering, Biomedical Engineering, Mechanical Engineering, Chemical Engineering, Life Sciences, or a related technical discipline.
• Typically 2-4 years of quality engineering experience within a regulated industry, preferably medical devices.
• Working knowledge of Quality Management Systems, ISO 13485, FDA Quality System Regulations, and medical device development processes.
• Experience supporting design controls throughout the product development lifecycle.
• Unde…