Quality Engineer

Roles & Responsibilities

• Perform equipment and process validation studies, including writing/reviewing protocols, reports, data analysis, and managing deviations.
• Ensure compliance with maintenance, preventive maintenance, calibration, and out-of-tolerance activities for medical devices or biological equipment.
• Author and execute installation, operational, and performance qualifications for analytical and manufacturing equipment.
• Execute validation and qualification of GMP equipment and functions within the manufacturing facility.
• Review and update FMEA or risk documents for validation activities.
• Support business continuity during manufacturing process relocation, including QA inspections, dual operation support, and document review for product release.

Experience Required

• 3–5 years of experience in the Medical Device, Biotech, or Pharma industry.
• 5–7 years of experience in the Medical Device, Biotech, or Pharma industry.

Skills & Certifications

• Strong verbal and written communication, with proficiency in writing technical documents.
• Knowledge of quality systems (ISO 9001, ISO 14971, ISO 13485) and methodologies.
• Proficiency in process and equipment validation, risk management, and supplier management.
• Basic statistical analysis knowledge (e.g., Minitab, Excel).
• Hands-on experience with Six Sigma methodologies.
• Familiarity with SAP and equipment management systems (e.g., BMRAM).
• Ability to work both independently and in teams with minimal supervision.
• Strong organizational skills with the ability to multitask.

Eligibilities & qualifications

• Bachelor’s degree in Biological Sciences, Chemistry, Biotech Engineering, Bioengineering, or a related field.