Quality Engineer

Key Responsibilities

• Support Quality Management System (QMS) activities and ensure compliance with FDA, cGMP, and ISO 13485 requirements.
• Review and approve deviations, non-conformances, CAPAs, and change controls.
• Conduct root cause investigations and implement corrective and preventive actions.
• Support internal, customer, and regulatory audits and inspections.
• Review manufacturing, validation, and quality documentation for compliance.
• Perform risk assessments and quality impact evaluations.
• Monitor quality metrics and identify opportunities for continuous improvement.
• Support supplier quality activities, including qualification and performance monitoring.
• Collaborate with cross-functional teams to ensure quality requirements are met throughout the product lifecycle.
• Assist in process validation, equipment qualification, and product quality improvement initiatives.

Required Qualifications

• Bachelor's degree in Engineering, Life Sciences, Quality, or a related field.
• 3+ years of Quality Engineering experience in Medical Device, Pharmaceutical, or Biotechnology industries.
• Knowledge of FDA regulations, cGMP, ISO 13485, and quality systems.
• Experience with CAPA, deviations, change control, and investigations.
• Strong problem-solving and root cause analysis skills.
• Excellent communication and documentation skills.

Pay

TBD

Schedule

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Benefits

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Skills

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Benefits

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