Senior Quality Engineer

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

Find a position that matches your potential.

Southern California

Senior Quality Engineer

We are partnering with a leading in medical device instrumentation company in Southern California to identify a Senior Quality Engineer to join their team. Local candidates only.

What’s in it for you…

• Well-established & growing company – private equity owned
• New leadership team as of 8 years ago – has made a huge difference
• Huge growth potential for the company in this industry
• Great boss – approachable, understanding & easy to work
• Incredible job satisfaction – every individual makes an impact

To be considered for an interview, the following experience/skills are desired:

• 5+ years of quality engineering experience in a regulated industry (medical, aerospace or auto)
• Medical device onsite manufacturing experience (Class I or II)
• Demonstrated knowledge and understanding of FDA regulations, Quality System Regulations 21 CFR Part 820, ISO 13485, EU MDR, ISO 14971
• Experience working with new product launch teams
• Excellent computer proficiency (MS Office – Word, Excel, and Outlook)
• Strong analytical skills with the application of statistical methods (e.g., SPC, DOE, capability analysis, etc.)
• Must be able to work under pressure and meet deadlines, while maintaining a positive attitude and providing exemplary customer service
• Experience with equipment and process validation (IQ, OQ,PQ)