Senior Quality Engineer

Overview

Senior Supplier Quality Engineer in the Toxicology Business Unit, Rapid and Molecular Diagnostics Division, based in Pomona, CA. Responsible for quality engineering activities covering product and process changes, quality issues and resolution, complaint handling, and compliance.

What you'll do

• Drive continuous process improvement by partnering with Operations to improve processes and resolve issues.
• Support the development, implementation, and monitoring of process control systems and Critical-to-Quality (CTQ) measures to ensure products consistently meet internal, customer, and regulatory requirements, including participation with non-conformance, CAPA, and complaints.
• Administer Enterprise software for complaint handling; lodge and investigate customer inquiries and complaints.
• Adhere to regulatory compliance requirements for issue reporting to regulatory bodies.
• Provide Quality Assurance support for IVD medical device development and lifecycle management, ensuring compliance with design controls, risk management, quality planning, verification, validation, and change control processes.
• Support risk management activities, including risk assessments, FMEA, and failure mode analysis, to identify potential issues and implement effective mitigation strategies.
• Investigate, resolve, and prevent product and process nonconformances through structured problem-solving, root cause analysis, CAPA, and quality improvement methodologies.
• Administer resolution of non-conformances and CAPA in Enterprise applications in conjunction with key stakeholders.
• Collaborate cross-functionally with R&D, Manufacturing, Quality Control, Applications Support, and Design Engineering teams to proactively address quality challenges and drive effective solutions.
• Manage multiple projects and priorities while providing leadership, coaching, and mentorship to support team development and successful project execution.
• Ensure compliance with Quality Management Systems (QMS), ISO, FDA, EMS, and company policies by supporting audits, regulatory requirements, documentation, validation activities, and continuous quality system improvement.

What you'll need

• Bachelor's in a field of science such as Chemistry, Microbiology, Biology, Biochemistry, or Engineering.
• Minimum 5 years of experience in a quality role within the biotechnology industry, with 3-5 years of progressive responsible positions.

Nice to have

• Direct work experience in IVD or medical device/biotech or regulated manufacturing environment.
• ASQ CQE or other certifications.
• Strong project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner.
• Experience including new product development, design transfer, validation, QMS, and Supplier Audit experience.
• Experience with reagent, ELISA, HEIA manufacturing.
• Lean Six Sigma (Black or Green Belt), Certified Quality Engineer, Certified Quality Auditor.
• Demonstrated supervisory experience.
• Knowledge of IVDR in EU, FDA QSRs, ISO 13485:2016, ISO 14971:2012 standards and HACCP, GMP, GLP and GDP requirements.

Details

• Location: Pomona, CA (829 Towne Center Drive).
• Work shift: Standard.
• Travel: Yes, 25% of the time.
• Significant work activities include prolonged sitting and standing, keyboard use (50% or more of the workday), and routine work with chemicals.
• Base pay: $90,000.00 – $180,000.00; the range may vary in specific locations.