Senior Quality Engineer - Medical Devices & NPI Leader

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

Benefits offered by this job

401K Match

Diversity & Inclusion

Corporate Events

Sustainability & Social Commitment

Employee discounts

Job summary

Freudenberg Medical LLC in Baldwin Park, CA is seeking a Sr. Quality Engineer to lead quality programs in medical manufacturing.

The role emphasizes ISO 13485 compliance, GMP, and NPI quality activities with CAPA, audits, and supplier quality coordination. The candidate will apply DOE, FMEA, SPC, MSA, control plans, and risk management to ensure product quality from design through production, mentor junior staff, and collaborate across engineering, operations, and regulatory teams.

Qualifications

• Bachelor's degree in Engineering, Chemistry, Biology, or related field.
• 8+ years’ quality engineering experience in the medical device industry.
• Strong knowledge of GMP and ISO 13485/14001/14971.
• Experience with DOE, FMEA, Control Plan, MSA, SPC, GD&T.
• Leadership in audits and CAPA processes.
• Lean/Six Sigma certification is a plus.

Responsibilities

• Lead site-wide quality initiatives and standardization.
• Apply statistical tools to analyze data and drive improvements.
• Lead NPI quality activities and design transfer (IQ/OQ/PQ, FMEA).
• Manage CAPA Review Board and provide solutions to senior management.
• Mentor Quality Engineers and Technicians for daily support.

Skills

Quality engineering

GMP

CAPA

Root cause analysis

DG/T quality tools

Education

Bachelor's degree in Engineering

Tools

Minitab

SPC

DOE

FMEA

Job description

Freudenberg Medical LLC in Baldwin Park, CA is seeking a Sr. Quality Engineer to lead quality programs in medical manufacturing.

The role emphasizes ISO 13485 compliance, GMP, and NPI quality activities with CAPA, audits, and supplier quality coordination. The candidate will apply DOE, FMEA, SPC, MSA, control plans, and risk management to ensure product quality from design through production, mentor junior staff, and collaborate across engineering, operations, and regulatory teams.