Senior Quality Engineer

We are seeking a Quality Assurance Engineer responsible for establishing, maintaining, and improving the Quality Management System to ensure that products and processes meet quality requirements, applicable regulations, and customer expectations.

Responsibilities

• Maintain and improve the Quality Management System and prevent product and process defects.
• Lead and participate in internal and external audits.
• Manage corrective and preventive actions (CAPA), complaint investigations, and trend analysis.
• Perform root cause analysis and support the disposition of nonconforming products.
• Support test method validation (TMV) and manufacturing line validation through IQ, OQ, PQ, and PPQ.
• Drive continuous improvement using Six Sigma, statistical tools, and Design of Experiments (DOE).
• Participate in change control and risk analysis while preserving product integrity and design requirements.
• Support changes to materials, processes, methods, specifications, and supply sources.
• Collect, analyze, and report quality system performance metrics.
• Collaborate with Production, Facilities, Maintenance, and EHS.
• Support plant implementation and manufacturing line transfers.
• Directly supervise quality technicians and inspectors and indirectly supervise other quality engineers.
• Promote a culture of quality, customer service, and safety.

Requirements

• A bachelor’s degree or higher in Industrial, Biomedical, Mechanical, Chemical, Electrical, or Mechatronics Engineering, or Microbiology.
• At least 3 years of experience in engineering, quality, or similar technical roles, including involvement in establishing, controlling, and improving quality systems.
• Practical knowledge of root cause analysis, change control, and risk analysis.
• Statistical knowledge and familiarity with Lean Six Sigma or continuous improvement methodologies.
• Knowledge of ISO 13485, MDSAP, ANVISA, FDA requirements, 21 CFR Part 11, and EU MDR.
• Upper-intermediate English.
• Proficiency in Microsoft Office: Word, Excel, PowerPoint, and Teams.

Preferred Qualifications

• Experience in medical device or pharmaceutical manufacturing.
• Certifications in ISO 13485, ISO 9001, or ISO 17025.
• Lean Six Sigma or ASQ certification.