Quality Assurance Engineer

Overview: 

The Quality Assurance Engineer supports the Quality organization by driving compliance, continuous improvement, and operational excellence within a regulated manufacturing environment. This role is responsible for conducting investigations, managing document and process changes, supporting audits, and ensuring adherence to quality systems and Good Manufacturing Practices (GMP). The position requires a hands-on, analytical individual capable of collaborating across departments to identify root causes, implement corrective actions, and maintain compliance with global regulatory standards.

Job Responsibilities:

• Conduct and document investigations related to process deviations, nonconformances, and quality events, ensuring timely and effective resolution.
• Develop and implement corrective and preventive actions (CAPAs) to prevent recurrence of quality issues.
• Generate, revise, and review controlled documents such as batch records, procedures, test methods, and specifications.
• Apply structured problem-solving and risk assessment tools such as FMEA, fishbone analysis, 5-Why, and risk matrices to support investigations and process improvement efforts.
• Analyze process and quality data to identify trends, cost savings, and improvement opportunities.
• Support and participate in internal and external audits conducted by regulatory authorities or clients.
• Ensure full compliance with applicable global regulations and guidelines, including cGMP, ISO, and other relevant quality standards.
• Contribute to annual product quality reviews and continuous improvement projects.
• Promote a culture of safety, quality, and compliance through adherence to SOPs, training, and ongoing awareness.
• Maintain current knowledge of domestic and international quality requirements and industry best practices.
• Collaborate with cross-functional teams to ensure effective communication and alignment on quality initiatives.

Job Qualifications:

• Bachelor’s degree in a scientific or engineering discipline (Biology, Chemistry, or related field preferred); equivalent experience may be considered.
• Minimum of three years of relevant experience in quality, manufacturing, or regulated operations.
• Strong understanding of GMP principles and regulatory compliance in a technical or manufacturing setting.
• Proficiency in using Microsoft Office and other data management or documentation systems.
• Excellent analytical, problem-solving, and decision-making skills with experience using quality tools and methodologies.
• Strong written and verbal communication skills, with attention to accuracy and clarity in documentation.
• Ability to manage multiple priorities, work independently, and collaborate effectively with cross-functional teams.
• Consistent, reliable attendance and a proactive, high-energy approach to supporting quality operations.