Senior Quality Engineer

About the role

As a Senior Quality Engineer, you will lead quality improvement initiatives across product development, manufacturing, supplier quality, and quality systems. You'll work closely with cross-functional teams to solve complex quality challenges, drive corrective actions, and ensure compliance with industry standards and regulatory requirements.

Responsibilities

• Partner with cross-functional teams on new product and service development projects, ensuring quality requirements are met throughout the product lifecycle.
• Lead investigations, root cause analyses, corrective actions, and continuous improvement initiatives.
• Develop and implement statistical methods including sampling plans, process capability studies, SPC, trend analysis, and designed experiments.
• Analyze quality data and recommend process and product improvements.
• Drive quality system enhancements and support ongoing compliance initiatives.
• Lead supplier quality audits and corrective action programs.
• Support internal and external audits, including regulatory and certification audits.
• Evaluate and disposition nonconforming materials and processes.
• Develop quality metrics, analyses, and reports to measure system performance.
• Train and mentor employees on quality principles, problem-solving methodologies, and statistical techniques.
• Collaborate with teams across manufacturing, operations, engineering, and supply chain to improve quality performance.

Requirements

• Bachelor's degree in Engineering, Quality, Manufacturing, or a related technical field.
• 6–10 years of combined Quality Engineering, Manufacturing Engineering, and/or Quality Systems experience.
• 6–10 years of experience working within an ISO-certified environment.
• Strong knowledge of quality tools, methodologies, and continuous improvement practices.
• Experience leading root cause investigations and corrective actions.
• Excellent analytical, organizational, and problem-solving skills.
• Strong verbal and written communication skills.
• Proficiency with Microsoft Office applications including Excel, Word, and PowerPoint.

Preferred Qualifications

• Experience in medical device, healthcare, or other regulated industries.
• Knowledge of FDA Quality System Regulations, GMP, and related regulatory requirements.
• AQS certification or similar quality certification.
• Experience with statistical analysis software and Visio.
• Prior experience leading or supervising quality personnel.