Sustaining Quality Engineer – Medical Device – Aliso Viejo, CA

Aliso Viejo, CA 92656

Posted: 10/23/18 Employment Type: Direct Hire Industry or Function: Engineer Job Number: 69292-TM Compensation: $ 85,000 to $ 100,000

JOB #: 69292-TM

KEY WORDS: quality, engineer, CAPA, SCARs, ECOs, manufacturing, sustaining, validation, IQ/OQ/PQ, NCMR, FDA, medical device.

JOB DESCRIPTION: TriStaff is partnering with a late-stage startup class II medical device company in Aliso Viejo, CA to find 2 Quality Engineers for its team. These roles will be supporting released products. You’d be responsible for ensuring high quality components are manufactured and delivered to customers. The company offers a fast-paced, energetic, collaborative environment with opportunity for growth.

Job Duties:
• Manage Supplier Corrective Action Requests (SCARs)
• Lead CAPA and NCMR investigations
• Participate in supplier selection

Salary Range and Bonus Potential:
$ 85,000 to $ 100,000
• 10% bonus

• Company paid medical, dental, and vision insurance
• 401K plan
• PTO and holiday pay
• Stock options

Job Requirements:
• 3-5 years’ quality engineering experience within the medical device industry
• Experience with CAPAs, NCMRs, ECOs, SCARs
• Strong communication skills
• Strong writing skills

Educational Requirements:
• Bachelor’s degree in a related field


Megan Marsh

I am an East Coast native and earned a BA degree in Psychology from the University of Virginia. After recruiting for a year in Washington, D.C., I moved out to San Diego, CA and joined TriStaff in 2007 as a Technical Recruiter. Since 2013, I’ve been an Engineering & Executive Search Recruiter, specializing in hardware engineering recruitment within Southern California. The majority of my clients are small, well-funded startups within the medical device and consumer electronics industries. Positions that I specialize in: Mechanical Engineers, Electrical Engineers, Quality Assurance, Manufacturing Engineers, Systems Engineers, Operations, Project Managers. I’m also the proud mother of two strong-willed daughters, and my husband is the Director of Operations at a local startup Medical Device Company, so I’m deeply embedded in the engineering space!
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