Senior Quality Engineer - Medical Devices NPI & CAPA Lead

Freudenberg Medical LLC; Baldwin Park (CA); On-site; USD 95,000 - 115,000; Full time

Job summary

Freudenberg Medical LLC in California seeks a Site Subject Matter Expert on ISO elements to standardize processes and drive continuous improvement. You will balance compliance with lean systems, apply Minitab, Six Sigma, SPC and DOE to analyze data and support risk reduction initiatives.

You will lead CAPA reviews, train junior staff, and oversee design transfer, process validation, and audits. The role requires 8+ years in medical device quality engineering and strong regulatory knowledge.

Qualifications

• Bachelor's degree in engineering, chemistry, biology, or related field.
• 8+ years’ quality engineering in medical devices.
• Strong knowledge of ISO 13485, 21 CFR 820, MDSAP and GMP.
• Experience with DOE, FMEA, SPC, CP, MSA, GD&T and fixturing.
• Proven problem-solving, critical thinking, and leadership in audits.

Responsibilities

• Lead internal and external audits and coordinate inspections.
• Manage CAPA activities and report findings to senior management.
• Lead NPI QA activities, design transfer, IQ/OQ/PQ, and risk management.
• Mentor Quality Engineers and Technicians to sustain production quality.
• Collaborate cross-functionally to ensure change controls are tested and documented.

Skills

Quality engineering

Statistical methods

Design of Experiments

Process control

Root cause analysis

Education

Bachelor's degree in engineering/chemistry/biology

Tools

Minitab

SPC

FMEA

Control plans

Job description

Freudenberg Medical LLC in California seeks a Site Subject Matter Expert on ISO elements to standardize processes and drive continuous improvement. You will balance compliance with lean systems, apply Minitab, Six Sigma, SPC and DOE to analyze data and support risk reduction initiatives.

You will lead CAPA reviews, train junior staff, and oversee design transfer, process validation, and audits. The role requires 8+ years in medical device quality engineering and strong regulatory knowledge.