Quality Engineer

Designs, installs, and evaluates quality assurance process sampling systems, procedures, and statistical techniques; designs or specifies inspection and testing mechanisms and equipment; analyzes production and service limitations and standards; recommends revision of specifications when indicated; formulates or helps formulate quality assurance policies and procedures. May conduct training on quality assurance concepts and tools. Interfaces with all other engineering components within the organization and with customers and suppliers on quality related issues.

Typically a quality engineer has a degree in engineering or in a quality related discipline.

Key Skills a Quality Engineer should possess are

• Coordinating the activities of the Quality resources allocated to the department to ensure optimal efficiency and compliance with all regulatory requirements.
• Drive and maintain cGMP practice within the department.
• Preparation, review and approval of technical documentation
• Ensure all related CAPA’s are completed in compliance with all regulatory and procedural commitments.
• Drive root cause analysis of non conformances with the department subject matter experts.
• Become an active member of the site internal audit team, liaising with Regulatory auditors
• Devise and implement Six Sigma continuous improvement projects
• Ensure support area operates in accordance with current best practice.
• Act as customer liaison contact for given key customers.
• Review, analyse and report on relevant customer complaints.
• To carry out Quality and Regulatory Compliance functions within the Quality Engineering Team