Quality Engineer

Hiring Quality Engineer

Job Summary

We are seeking a Quality Engineer with 2 plus years of experience in a regulated environment. The ideal candidate will have hands on experience in quality systems compliance and process improvement with a strong understanding of GMP standards and regulatory requirements

Key Responsibilities

Support and maintain Quality Management System activities including deviations CAPA change control and investigations

Review and approve quality documentation such as SOPs protocols reports and batch records

Perform root cause analysis and implement corrective and preventive actions

Ensure compliance with cGMP GxP and regulatory requirements

Support internal audits external audits and regulatory inspections

Collaborate with manufacturing engineering and QA teams to improve product quality and process efficiency

Participate in risk assessments gap analysis and continuous improvement initiatives

Ensure data integrity and adherence to ALCOA plus principles

Required Qualifications

Bachelor’s degree in Engineering Life Sciences Pharmacy or related field

Minimum 2 plus years of experience in quality engineering or quality assurance in pharma biotech or medical device industry

Required Skills

Strong knowledge of cGMP GxP regulations and quality systems

Experience with deviation CAPA change control and investigations

Understanding of data integrity and regulatory compliance

Good documentation problem solving and communication skills