Senior Quality Engineer

What you'll do

• Lead quality operations and decision-making regarding daily activities to ensure compliance with FDA and ISO standards.
• Analyze quality data and performance trends using AI, Power BI, and Excel to identify process improvements.
• Manage complaint handling and manufacturing assessments to ensure product safety and quality.
• Lead projects focused on incoming inspection, material acceptance, and product release processes.
• Develop and maintain quality procedures, controls, and protocols for materials, components, and finished products.
• Design and evaluate inspection and testing methods to verify product and process conformity.
• Investigate nonconformances to determine root causes and implement corrective and preventive actions (CAPA).
• Ensure all quality documentation and records meet regulatory requirements and internal quality system standards.

What we're looking for

• A Bachelor's degree with 4+ years of experience, a Master's degree with 2+ years of experience, or a PhD is required.
• Candidates must possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.
• Experience in the medical device industry supporting manufacturing, quality, or regulatory functions is preferred.
• Working knowledge of FDA QSR, ISO 13485, ISO 14971, and GMP standards is preferred.
• Experience with audit planning, execution, complaint handling, and supplier or internal quality audits is preferred.
• Experience leading continuous improvement, Lean Manufacturing, Six Sigma, CAPA, and root cause investigation is preferred.
• Proficiency in statistical analysis tools including Minitab, Microsoft Excel, and Power BI is preferred.
• ASQ Certified Quality Engineer (CQE) or comparable quality certification is preferred.