Senior Quality Engineer – Medical Devices, Growth

MRIGlobalSearch; California (MO); On-site; USD 120,000 - 150,000; Full time

Job summary

MRIGlobal in Southern California is seeking a Senior Quality Engineer to join a leading medical device instrumentation company. Local candidates only.

You will work with cross-functional teams on quality systems, regulatory compliance, and product launches. The role requires 5+ years in quality engineering within regulated environments, hands-on experience with FDA QSR and ISO standards, and strong analytical skills.

Qualifications

• 5+ years of quality engineering in regulated industries (medical, aerospace, or auto).
• Medical device onsite manufacturing experience (Class I or II).
• Knowledge of FDA regulations, QSR 21 CFR Part 820, ISO 13485, EU MDR, ISO 14971.
• Experience with new product launch teams.
• Proficient with MS Office (Word, Excel, Outlook).
• Strong analytical skills using statistical methods (SPC, DOE, capability analysis).
• Ability to work under pressure to meet deadlines and provide good customer service.
• Experience with IQ, OQ, PQ equipment and process validation.

Skills

Quality engineering experience

FDA regulations knowledge

Statistical methods

MS Office proficiency

Product launch experience

Regulated industry experience

IQ/OQ/PQ experience

Job description

MRIGlobal in Southern California is seeking a Senior Quality Engineer to join a leading medical device instrumentation company. Local candidates only.

You will work with cross-functional teams on quality systems, regulatory compliance, and product launches. The role requires 5+ years in quality engineering within regulated environments, hands-on experience with FDA QSR and ISO standards, and strong analytical skills.