GerTEK is an engineering consultancy company specialising in project management, talent solutions and commissioning qualification and validation services. We partner with many of the world’s largest life science & have multiple projects that we support,

Quality Engineer

Quality Assurance Specialist

• Ensure products meet specifications and site activities follow good manufacturing practices (GMP) and regulatory requirements.
• Work within the Quality Team to achieve quality goals and ensure all actions comply with GMP.

Key Responsibilities:

• Coordinate and ensure compliance with assigned parts of the Quality System.
• Participate in quality system audits.
• Help investigate customer complaints and implement corrective/preventive actions (CAPA).
• Manage the CAPA process: initiation, investigation, correction, and preventative actions.
• Track and report on Quality System performance metrics.
• Provide necessary quality-related training to plant personnel.
• Keep Management informed of system failures for timely corrective/preventive action and product containment.
• Verify the effectiveness of corrective/preventive actions.
• Ensure compliance with relevant regulatory requirements.
• Assist with validation activities at the site.
• Maintain thorough, complete, and compliant Quality System documentation.
• Ensure training compliance is maintained.
• Review lot records for compliance and complete lot release for shipment.
• Inspect incoming products and manage supplier quality relationships.
• Participate in continuous improvement programs for quality, safety, environmental, and production systems.
• Perform in-process and final product testing according to specifications and procedures.
• Review batch records for compliance (where required).
• Make disposition decisions for batches.
• Participate in Risk Management activities as needed.

Essential Requirements:

• Degree in Engineering, Science, Quality, or a related field.

Experience Required:

• Minimum 2 years of experience in the daily operation of a quality system in a highly regulated combination product/device manufacturing environment.
• Minimum 2 years working knowledge of quality system regulations (ISO13485/ISO9000; CFR 21 Part 820) or specific elements like process validation, design controls, CAPA, auditing, etc.