Premierehire is working with a Carlsbad based medical device company that is seeking a Quality Engineer (QE). The QE will be responsible for working side by side the Director of Quality to maintain and implement an 21CFR Part 820 and ISO13485 Quality System that is compliant with the law.
Type: Full time, M-F 8-5 – Direct Hire
Pay: 100K – 110K plus yearly bonus
This position will have a strong emphasis on:
• Assist in root cause analysis, corrective and preventative actions
• Develop, write, implement and train to Quality System processes
• Maintain DHFs in compliance to established procedures
• Guidance to (DC) teams in accordance to established procedures
• Provide trend analysis on Quality Systems for process / product improvement efforts
• BS degree in science or technical discipline or higher
• 5 – 7 years of experience n a QE position with a Medical Device company is a must
• Solid Works – proficiency needed
• Experience with Class III products is a plus but is not necessary
• Global Quality Systems experience needed, such as ISO13485, QSR’s and others along with Medical Device Regulations – MDD, SOR, CFR, and etc.
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Premierehire is the recruiting arm for an exclusive base of extraordinary companies in San Diego County helping them find and engage top talent for full time career opportunities. We work closely with you to ensure the opportunity is a good fit and to provide you with the tools and preparation for a great new hire experience.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.