Senior Quality Engineer, Medical Device & IVD

Thornton Tomasetti; Pomona (CA); Sur place; USD 90 000 - 180 000; Plein temps

Résumé du poste

Abbott in Pomona, CA is seeking a Senior Supplier Quality Engineer to lead quality engineering activities addressing product and process changes, quality issues, and regulatory compliance within the Diagnostics Division.

You will partner with Operations to drive process improvement, implement CTQ metrics, support design controls, risk management, CAPA, and cross-functional teams to ensure products meet internal, customer, and regulatory requirements.

Qualifications

• Bachelor's in fields of science such as Chemistry, Microbiology, Biology, Biochemistry, or Engineering.
• Minimum 5 years experience in a quality role within the biotechnology industry with 3-5 years of progressive responsible positions.
• Direct work experience in IVD or medical device/biotech or regulated manufacturing environment preferred.
• ASQ CQE or other certifications preferred.

Responsabilités

• Drive continuous process improvement by partnering with Operations to conduct process audits, identify opportunities, and implement sustainable enhancements that improve quality, efficiency, and compliance.
• Lead the development, implementation, and monitoring of process control systems and CTQ measures to ensure products meet requirements.
• 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.
• Lead risk management activities, including risk assessments, FMEA, and failure mode analysis, to identify potential issues and mitigate risks.
• Investigate, resolve, and prevent product and process nonconformances through CAPA and structured problem-solving.

Connaissances

Quality Assurance

Process Improvement

FMEA

CAPA

Lean Manufacturing

Six Sigma

Project Management

Regulatory Compliance

Formation

Bachelor's degree in Chemistry, Microbiology, Biology, Biochemistry, or Engineering

Description du poste

Abbott in Pomona, CA is seeking a Senior Supplier Quality Engineer to lead quality engineering activities addressing product and process changes, quality issues, and regulatory compliance within the Diagnostics Division.

You will partner with Operations to drive process improvement, implement CTQ metrics, support design controls, risk management, CAPA, and cross-functional teams to ensure products meet internal, customer, and regulatory requirements.