Senior Quality Engineer

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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)