Engineer II - Quality Engineer

In this role, you will apply quality engineering principles and methods to ensure compliance with regulatory requirements and company quality systems while supporting product development, manufacturing, and distribution.

Key responsibilities include:

• Investigating manufacturing product quality and compliance issues, including CAPAs, non-conformances, and audit observations.
• Developing and executing experiments and tests to create, validate, and improve products and manufacturing processes.
• Analyzing test and investigation results, making recommendations, and developing technical reports.
• Optimizing manufacturing processes using engineering methods such as Six Sigma and Lean.
• Identifying opportunities to redesign or improve equipment, tools, fixtures, and manufacturing processes to reduce risk and improve efficiency.
• Supporting continuous improvement initiatives related to product quality, manufacturing processes, and compliance.
• Ensuring compliance with applicable quality systems, regulatory requirements, and company procedures.

• Investigate moderately complex manufacturing quality and compliance issues across production processes prior to final product release.
• Develop, write, and execute protocols for moderately complex experiments and tests, including evaluation of source materials, suppliers, products, and manufacturing methods.
• Analyze data and test results, develop recommendations, and prepare technical reports.
• Optimize manufacturing processes using engineering principles and continuous improvement methodologies such as Six Sigma and Lean.
• Identify opportunities for the redesign or development of basic equipment, tools, and fixtures to improve manufacturing processes and reduce risk.
• Develop, update, and maintain technical content within risk management files.
• Develop training materials, work instructions, and other documentation to support production and enable effective knowledge transfer.
• Assign support tasks and provide direction to technicians conducting tests and other activities.
• Train technicians, provide feedback, and coordinate technician activities as needed.
• Support vendor and project stakeholder relationships and collaborate effectively with cross-functional teams.
• Perform other incidental duties as assigned by leadership.

• Good documentation, communication, and interpersonal skills, including negotiation and relationship management.
• Basic understanding of statistical techniques.
• Previous experience working with laboratory or industrial equipment.
• Solid understanding of engineering principles, theories, and concepts.
• Strong problem-solving, organizational, analytical, and critical thinking skills.
• Solid understanding of manufacturing processes and equipment used in assigned work.
• Knowledge of and adherence to quality systems and procedures.
• Ability to read and interpret engineering drawings.
• Proficiency with Microsoft Office Suite and related computer applications.
• Strong attention to detail and commitment to accuracy.
• Ability to interact professionally with individuals at all organizational levels.
• Ability to manage competing priorities in a fast-paced environment.
• Ability to work effectively in a team environment and manage vendors and project stakeholders.
• Ability to build productive internal and external working relationships.
• Ability to follow company rules and requirements, including Environmental Health & Safety protocols and measures designed to prevent injuries and protect the environment.

• Bachelor's degree in Engineering required.
• 2-4 years of relevant engineering experience required.
• Experience applying quality engineering principles in a manufacturing environment preferred.
• Experience with quality systems, CAPA, non-conformances, audits, risk management, and continuous improvement preferred.
• Experience with Six Sigma and Lean methodologies preferred.