Senior Quality Engineer – Medical Devices, NPI & CAPA Lead

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

Job summary

Freudenberg Group in Baldwin Park, CA is seeking a Sr. Quality Engineer for medical manufacturing. You will act as site SME on ISO quality elements, lead cross-functional teams, and apply Six Sigma and DOE to improve processes.

You will drive design transfer, process validation, risk management (FMEA), supplier quality, and CAPA programs, while mentoring junior engineers and ensuring compliance with 21 CFR 820 and ISO 13485.

Qualifications

• Bachelor's degree in Engineering, Chemistry, Biology or related science/technical field.
• 8+ years’ quality engineering experience in the medical device industry.

Responsibilities

• Lead CAPA Review Board and provide working solutions aligning with compliance and business needs.
• Lead NPI Quality Activities and design transfer (IQ/OQ/PQ), risk management (FMEA), and regulatory compliance.
• Lead supplier quality activities including supplier selection, qualification, audits, and quality agreements.
• Lead internal and external audits and manage audit programs with site leadership.

Skills

Statistical methods

Six Sigma

DOE

FMEA

CAPA

Audits leadership

Root cause analysis

ISO standards

Education

Bachelor's degree in Engineering, Chemistry, Biology, or related science/technical field

Tools

Minitab

Job description

Freudenberg Group in Baldwin Park, CA is seeking a Sr. Quality Engineer for medical manufacturing. You will act as site SME on ISO quality elements, lead cross-functional teams, and apply Six Sigma and DOE to improve processes.

You will drive design transfer, process validation, risk management (FMEA), supplier quality, and CAPA programs, while mentoring junior engineers and ensuring compliance with 21 CFR 820 and ISO 13485.