Quality Engineer

We are seeking a detail oriented Quality Engineer to support quality assurance, quality engineering, compliance, and continuous improvement activities within a GMP-regulated pharmaceutical or biotechnology manufacturing environment.

The ideal candidate will have experience with quality management systems, deviations, CAPA, change control, risk assessments, investigations, and audit readiness. The role will involve collaboration with engineering, manufacturing, validation, and other cross-functional teams to maintain product quality, patient safety, and regulatory compliance.

Key Responsibilities:

• Support the implementation and maintenance of the site's Quality Management System (QMS).
• Review, investigate, and document deviations, nonconformances, and quality events.
• Perform root cause analysis using appropriate methodologies, including 5 Whys and fishbone diagrams.
• Initiate, track, and verify corrective and preventive actions (CAPA).
• Support change control assessments for equipment, processes, utilities, automation systems, and procedures.
• Review and approve applicable SOPs, work instructions, protocols, reports, and other controlled documents within assigned responsibilities.
• Support equipment qualification, process validation, and computerized system validation activities.
• Participate in risk assessments, quality impact assessments, and continuous improvement initiatives.
• Support internal audits, external inspections, and regulatory compliance activities.
• Ensure adherence to applicable GMP requirements, data integrity principles, and site quality standards.
• Collaborate with engineering and manufacturing teams to assess quality risks associated with equipment failures, process changes, and maintenance activities.
• Monitor quality metrics and support timely closure of deviations, CAPAs, and change controls.
• Assist with training, documentation compliance, and inspection readiness activities.

Required Qualifications:

• Bachelor's degree in Engineering, Pharmaceutical Sciences, Chemistry, Biotechnology, or a related field.
• 3–7 years of experience in quality engineering, quality assurance, or a related role in a regulated industry.
• Working knowledge of GMP requirements and pharmaceutical quality systems.
• Experience with deviations, CAPA, change control, root cause analysis, and risk management.
• Strong technical writing, documentation, and investigation skills.
• Ability to work effectively with cross-functional engineering, manufacturing, and quality teams.
• Strong attention to detail and a commitment to compliance and continuous improvement.