Quality Engineer

Responsibilities

• Support and maintain Quality Management System (QMS) processes in accordance with applicable regulatory requirements and internal procedures.
• Lead investigations related to nonconformances, deviations, complaints, and CAPAs.
• Analyze quality metrics and trends to identify opportunities for process improvement and risk reduction.
• Develop, implement, and improve incoming, in-process, and final inspection procedures.
• Review and approve quality records, specifications, procedures, and other controlled documentation.
• Collaborate with Manufacturing and Engineering teams to resolve quality issues and implement corrective actions.
• Support equipment qualification and process validation activities, including IQ, OQ, and PQ protocols.
• Participate in design transfer, manufacturing scale-up, and process improvement initiatives.
• Conduct root cause analysis using structured problem-solving methodologies.
• Support internal, customer, supplier, and regulatory audits.
• Train personnel on quality procedures, GMP requirements, and quality best practices.

Requirements

• Support and maintain Quality Management System (QMS) processes in accordance with applicable regulatory requirements and internal procedures.
• Lead investigations related to nonconformances, deviations, complaints, and CAPAs.
• Analyze quality metrics and trends to identify opportunities for process improvement and risk reduction.
• Develop, implement, and improve incoming, in-process, and final inspection procedures.
• Review and approve quality records, specifications, procedures, and other controlled documentation.
• Collaborate with Manufacturing and Engineering teams to resolve quality issues and implement corrective actions.
• Support equipment qualification and process validation activities, including IQ, OQ, and PQ protocols.
• Participate in design transfer, manufacturing scale-up, and process improvement initiatives.
• Conduct root cause analysis using structured problem-solving methodologies.
• Support internal, customer, supplier, and regulatory audits.
• Train personnel on quality procedures, GMP requirements, and quality best practices.

Qualifications

• Bachelor's degree in Engineering, Quality, Life Sciences, or related technical discipline.
• 3+ years of Quality Engineering experience within a regulated industry such as medical device, biotechnology, diagnostics, pharmaceutical, or aerospace manufacturing.
• Strong knowledge of Quality Systems, CAPA, Nonconformance Management, Change Control, and Risk Management.
• Experience supporting FDA, ISO 13485, ISO 9001, or other regulated quality environments.
• Experience with process validation and equipment qualification activities (IQ/OQ/PQ).
• Strong understanding of statistical methods and quality tools.
• Experience conducting root cause investigations and implementing effective corrective actions.
• Excellent communication and cross-functional collaboration skills.

Preferred Qualifications

• ASQ Certified Quality Engineer (CQE) or equivalent certification.
• Experience supporting supplier quality programs.
• Knowledge of Minitab or other statistical analysis tools.
• Experience participating in FDA, Notified Body, or customer audits.