Senior Quality Engineer (Complaint Handling)

Abbott seeks a Senior Quality Engineer for its Pomona, California diagnostics facility to lead quality engineering activities across product and process improvements, compliance, and medical device development. The role involves process audits, risk management, problem-solving, and cross-functional collaboration within a regulated manufacturing environment.

Responsibilities

• Conduct process audits and lead continuous improvement initiatives with Operations teams
• Develop and monitor Critical-to-Quality measures and process control systems for regulatory compliance
• Provide Quality Assurance support for IVD medical device development including design controls and validation
• Lead risk assessments, FMEA, and failure mode analysis with mitigation strategy implementation
• Investigate nonconformances and execute CAPA and quality improvement methodologies

Requirements

• Bachelor's degree in Chemistry, Microbiology, Biology, Biochemistry, or Engineering
• Minimum 5 years quality role experience in biotechnology with 3-5 years progressive responsibility
• Direct work experience in IVD, medical device, biotech, or regulated manufacturing
• ASQ CQE or equivalent quality certification
• Knowledge of FDA QSRs, ISO 13485:2016, and ISO 14971:2012 standards
• Project management and leadership skills with demonstrated ability to lead cross-functional teams
• Lean Six Sigma certification (Black or Green Belt) preferred

Compensation: $90,000–$180,000 base