📢 Job Posting – Quality Engineer

Title: Quality Engineer

Location: Camarillo, CA (On-site)

Department: Quality

Reports To: Quality Manager

Employment Type: Full-time

🌟 About the Role

We are seeking a highly motivated Quality Engineer to support and drive quality performance across the manufacturing of single-use bioprocessing components used in biopharmaceutical production.

This role will be responsible for leading quality investigations, driving continuous improvement initiatives, and ensuring compliance with GMP and regulatory standards. The ideal candidate will collaborate cross-functionally with Manufacturing, Engineering, R&D, Supply Chain, and Regulatory teams to resolve quality issues and enhance product and process performance.

🔧 Key Responsibilities

Lead investigations related to product nonconformances, customer complaints, sterility concerns, and in-market quality issues
Perform root cause analysis and implement Corrective and Preventive Actions (CAPA)
Conduct risk and impact assessments and ensure timely closure of quality events
Partner with cross-functional teams to identify failure modes and implement process improvements
Support customer audits, supplier audits, and regulatory inspections
Drive continuous improvement initiatives using Lean, Six Sigma, SPC, PFMEA, and other tools
Improve manufacturing processes such as cleanroom assembly, extrusion, molding, and packaging
Ensure compliance with GMP, ISO standards, and regulatory requirements
Monitor quality metrics and report performance trends and risks to leadership
Support change control, validation activities, and risk management processes
Develop and maintain quality documentation, procedures, and training materials

🎓 Qualifications

Bachelor’s degree in Engineering, Biological Sciences, Chemistry, Bioprocess Engineering, or related field
5+ years of experience in quality within biotech, pharmaceutical, medical device, or related manufacturing
Experience working in GMP and/or cleanroom environments
Strong knowledge of quality systems: CAPA, nonconformances, change control, validation, and risk management
Familiarity with ISO 9001, ISO 13485, and/or FDA regulations (21 CFR Parts 210, 211, or 820)
Experience with continuous improvement methodologies (Lean, Six Sigma, SPC, PFMEA)
Strong problem-solving, analytical, and communication skills
Ability to work cross-functionally and lead initiatives across multiple teams

💡 Preferred Skills

Experience with extrusion, injection molding, sterile manufacturing, or packaging processes
Strong technical writing and documentation skills
Proven ability to manage multiple priorities in a fast-paced environment

🤝 Why Join Us?

Impact critical products used in biopharmaceutical manufacturing
Work in a highly regulated, high-quality environment
Collaborate with cross-functional global teams
Be part of a culture focused on continuous improvement and innovation

BioTalent

Latest Jobs

Quality Engineer