Quality Assurance Specialist – Medical Device – Irvine, CA

Irvine, CA 92618 | Direct Hire

Post Date: 05/21/18 Job ID: 68953-TM Industry or Function: Biotech-Science Compensation: $ 80,000 to $ 110,000

JOB #: 68953-TM

KEY WORDS: quality, CAPA, non-conformance, complaints, quality system, medical device, FDA, audit, QMS.


Do you like working in a small company environment where you have the opportunity to work in all areas of Quality? Do you like working independently but also collaboratively with a global team? Are you looking for the next step in your career? TriStaff is partnering with a startup medical device company to find a Quality Assurance Specialist for its team. In this role, you will report to the Senior Director, Quality Assurance and Regulatory Affairs, who has over 20 years industry experience. You will have the opportunity to work and be exposed to all areas of quality assurance – complaint handling, CAPAs, non-conformances, audits, etc.

If interested and qualified, please email your resume to Megan Marsh, mmarsh@tristaff.com.

Job Duties:
• Develop and implement systems to assure compliance with appropriate regulatory agencies
• Implement quality system procedures
• Review product complaints and ensure timely reporting
• Perform external audits
• Interface with suppliers, engineers, and contractors regularly
• Maintain customer complaint, Non-Conformance and CAPA system

Salary Range and Bonus Potential:
$ 80,000 to $ 110,000
• 10% annual bonus

• Medical, dental, vision insurance
• PTO and holiday pay
• Annual bonus
• Significant exposure to International team

Job Requirements:
• 3-5 years’ experience in Quality Systems within a medical device company
• Must be comfortable working in a very small company environment; occasionally you will be the ONLY person in the office
• Some experience with complaint handling, CAPAs, and non-conformances
• Strong communication skills both written and verbal

Educational Requirements:
• Bachelor’s degree



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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