Quality Engineer

Responsibilities

• Support investigation and root cause analysis of quality deviations, non-conformances, and out-of-specification (OOS) results
• Assist in the development, review, and execution of CAPAs (Corrective and Preventive Actions) to resolve quality issues and prevent recurrence
• Support process and equipment validation activities, including IQ/OQ/PQ protocols, in partnership with Process and Validation Engineering
• Review and approve batch records, manufacturing documentation, and change controls for compliance with cGMP and internal quality standards
• Assist in authoring, reviewing, and updating SOPs, quality plans, and technical documentation
• Participate in risk assessments (FMEA) for new and existing processes, equipment, and products
• Support internal audits and prepare for external regulatory inspections (FDA, ISO) by compiling documentation and quality data
• Collaborate with Manufacturing, Quality Assurance, Quality Control, and Regulatory Affairs to resolve quality issues in real time
• Monitor quality metrics and trends (defect rates, deviation frequency, CAPA closure rates) and support reporting to quality leadership
• Support supplier quality activities, including incoming material inspections and supplier corrective action requests (SCARs), as needed
• Ensure compliance with FDA regulations, cGMP, and internal quality management systems throughout all quality engineering activities
• Participate in continuous improvement initiatives (Lean, Six Sigma) to reduce variability and improve first-pass yield
• Maintain accurate, audit-ready documentation for all quality investigations, validations, and change control activities

Qualifications

Required:

• Bachelor's degree in Engineering (Chemical, Mechanical, Biomedical, Industrial, Pharmaceutical, or related field) or related science discipline
• 0–2 years of relevant experience (internships, co-ops, or entry-level roles in pharma/biotech/med device quality count)
• Basic understanding of cGMP, FDA regulations (21 CFR Part 210/211), and pharmaceutical quality systems
• Familiarity with root cause analysis tools (5 Why, fishbone/Ishikawa) and CAPA processes
• Proficiency with MS Office (Excel, Word, PowerPoint); familiarity with quality management systems (QMS) software a plus
• Strong written and verbal communication skills, with the ability to author clear, audit-ready technical documentation
• Ability to work effectively in a cross-functional, highly regulated team environment
• Willingness to work on the production floor, including gowning/cleanroom protocols as required