Quality Engineer

About the role

We are seeking a Quality Engineer to support validation, quality systems, and continuous improvement initiatives within our manufacturing environment. This role is responsible for developing and executing validation activities, leading quality investigations, analyzing process data, and partnering with cross-functional teams to ensure compliance with quality and regulatory standards.

Responsibilities

• Develop, execute, and maintain validation protocols and documentation, including IQ, OQ, and PQ activities.
• Support validation efforts for equipment, processes, facilities, cleaning systems, and software.
• Provide statistical analysis for manufacturing operations, product development, process trials, and validation projects.
• Lead and support CAPA activities, non-conformance investigations, and root cause analyses.
• Develop and maintain SOPs related to validation, quality, and risk management.
• Monitor and report customer Key Performance Indicators (KPIs).
• Conduct quality and engineering studies to improve manufacturing performance and product quality.
• Serve as the site administrator for Infinity QS (Statistical Process Control) software.
• Deliver training on quality-related topics, including SPC and CAPA principles.
• Collaborate with customers, suppliers, and internal teams on validation and continuous improvement initiatives.

Qualifications

• Bachelor’s degree in Engineering, Science, or a related technical field.
• Minimum of 3 years of engineering experience, preferably in a manufacturing environment.
• Experience developing and executing validation protocols (IQ/OQ/PQ).
• Strong understanding of quality systems, root cause analysis, CAPA, and process improvement methodologies.
• Experience in an FDA-regulated environment is preferred.
• Experience in medical devices, pharmaceuticals, diagnostics, nutritional products, or a similar regulated industry is a plus.
• Strong analytical, problem-solving, and communication skills.

Work Environment

• Manufacturing and office-based environment.
• Up to 10% travel may be required.
• Opportunity to work closely with cross-functional teams to drive quality, compliance, and operational excellence.

Pay

The pay range for this position is $75,000.00 – $90,000.00 per year. Individual compensation offered within this range will depend on qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. Eligibility requirements apply to some benefits.

Benefits

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)