Quality Engineer I

What you'll do

• Perform data-driven root cause analysis to investigate quality issues and implement corrective and preventive actions.
• Develop, modify, and maintain quality standards and protocols for processing materials into finished products.
• Design and specify inspection methods, testing mechanisms, and equipment to ensure product precision and accuracy.
• Conduct quality assurance tests and perform statistical analysis to evaluate non-conforming materials or products.
• Maintain documentation to ensure compliance with internal quality systems and external regulatory requirements.
• Support audits, validations, and risk management activities across the product lifecycle.
• Identify systemic quality risks and drive continuous improvement initiatives in collaboration with manufacturing teams.

What we're looking for

• Must possess a Baccalaureate degree in Engineering.
• Candidates must have unrestricted U.S. work authorization at the time of hire.
• Working knowledge of Manufacturing Execution Systems (MES) is preferred.
• Understanding of Quality Management Systems (QMS), including document control, nonconformance management, CAPA, and change management is preferred.
• Familiarity with regulatory standards such as FDA QSR and ISO 13485 is preferred.
• Experience with data analytics and statistical analysis to support quality investigations is preferred.
• Exposure to Six Sigma or Lean methodologies, including the DMAIC framework, is preferred.
• Hands-on experience with statistical software like Minitab or basic programming in VBA/Python is preferred.