Quality Engineer

Job Description

Job Description

PharmaBio Serv is seeking a Quality Engineer to support quality systems and compliance activities related to Corrective and Preventive Actions (CAPA) and raw material investigations . This role is critical in ensuring product integrity, regulatory compliance, and continuous improvement across manufacturing and supply chain operations.

Key Responsibilities :

Lead and manage CAPA investigations related to raw materials and manufacturing processes

Conduct thorough root cause analyses and implement effective corrective actions

Investigate non-conformances and material-related deviations

Collaborate with cross-functional teams including Manufacturing, R&D, and Supplier Quality

Support raw material qualification and ongoing quality monitoring

Maintain documentation in compliance with GMP, ISO 13485 , and internal SOPs

Participate in internal audits and support external regulatory inspections

Monitor and trend quality data to identify systemic issues and drive improvements

Ensure timely closure of CAPAs and documentation in quality systems

Ideal Candidate Profile :

Bachelor’s degree in Engineering, Chemistry, or related field

3+ years of experience in Quality Engineering within a regulated industry

Strong understanding of CAPA processes , root cause analysis tools (e.g., 5 Whys, Fishbone, FMEA)

Experience with raw material investigations and supplier interactions

Familiarity with ISO 13485 , FDA QSR, and GMP standards

Excellent communication and documentation skills

Proficiency in Microsoft Office and quality management systems (TrackWise or similar)

Company Description

Pharma-Bio Serv, a global consulting firm headquartered in Puerto Rico, has been dedicated exclusively to providing services to the largest biotechnology & bio-engineering companies within the regulated industry for more than 29 years. Since our inception, our services have resulted in a project experience level and personnel resource base ranking among the highest worldwide.

Company Description

Pharma-Bio Serv, a global consulting firm headquartered in Puerto Rico, has been dedicated exclusively to providing services to the largest biotechnology & bio-engineering companies within the regulated industry for more than 29 years. Since our inception, our services have resulted in a project experience level and personnel resource base ranking among the highest worldwide.