Quality Engineer II: QMS, Lean, & Risk in Med Devices

Abbott; Los Angeles (CA); Sur place; USD 90 000 - 180 000; Plein temps

Avantages offerts par ce poste

Free medical coverage

Retirement plan

Tuition reimbursement

Education benefits

Résumé du poste

Abbott is seeking a seasoned Quality Engineer to develop and maintain quality engineering methods across new product development, manufacturing, and systems support. The role emphasizes process control, problem solving, and cross-functional leadership.

Requirements include a Bachelor’s in engineering, 5+ years of experience, and knowledge of FDA, GMP, ISO standards. Strong communication and project management skills are essential as you drive quality improvements in a matrixed environment.

Qualifications

• Bachelors Degree in Engineering or Technical Field or equivalent combination of education and experience.
• Experience with quality engineering in medical devices and manufacturing.
• Familiarity with FDA, GMP, ISO 13485, ISO 14971 required or preferred.

Responsabilités

• Identify and implement effective process control systems to support development, qualification, and manufacturing.
• Lead, coach, and mentor personnel across levels.
• Assist in development and execution of streamlined business systems to identify and resolve quality issues.
• Apply systematic problem-solving to prioritize and resolve quality issues.
• Design and conduct experiments for process optimization and improvement.
• Document experiment plans and results, including protocols and reports.
• Lead process control and monitoring of CTQ parameters and specifications.
• Lead quality improvement methodologies (Six Sigma, Lean) implementations.
• Investigate, resolve, and prevent product/process nonconformances.
• Participate in cross-team quality decisions and practices as Core Team member.
• Maintain risk analysis and support product verification/validation with design.

Connaissances

Supervisory experience

Quality tools/methodologies

FDA GMP ISO 13485 ISO 14971

Statistical data analysis

Project management

Communication skills

Formation

Bachelor's Degree in Engineering or Technical Field

Outils

Six Sigma

Lean Manufacturing

Description du poste

Abbott is seeking a seasoned Quality Engineer to develop and maintain quality engineering methods across new product development, manufacturing, and systems support. The role emphasizes process control, problem solving, and cross-functional leadership.

Requirements include a Bachelor’s in engineering, 5+ years of experience, and knowledge of FDA, GMP, ISO standards. Strong communication and project management skills are essential as you drive quality improvements in a matrixed environment.