Quality Assurance Specialist – Medical Device – Irvine, CA
Irvine, CA 92618 | Direct Hire
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, firstname.lastname@example.org.
• 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
• 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
• LOCAL CANDIDATES ONLY!!!
• Bachelor’s degree
FOR OTHER OPPORTUNITIES AND TO REGISTER WITH TRISTAFF, PLEASE VISIT OUR WEBSITE AT www.tristaff.com