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Sr. Quality Assurance Manager
EvolusNewport Beach, United Statesfull_timeVerifiedPosted 2 Sept 2025
💰 $190,000/yr($163,000/yr – $190,000/yr)
About the role
Evolus is a performance beauty company with a customer-centric approach focused on delivering breakthrough products. We are seeking an experienced and driven Sr. Quality Assurance Manager to join our Quality Assurance and CMC Team reporting to the Director, Quality Assurance. In this role, you will be responsible for maintaining the medical device Quality Management System (QMS).
If you join our team, you will be working on some of the most exciting opportunities and challenges we face, with a team that values growth, recognition, and camaraderie. If you are looking for an opportunity to exhibit your knowledge and technical abilities in a unique environment, then look no further! In this role, you will be challenged to drive the success of Evolus in an effort to build a brand like no other Essential duties and responsibilities where you'll make the biggest impact…
If you join our team, you will be working on some of the most exciting opportunities and challenges we face, with a team that values growth, recognition, and camaraderie. If you are looking for an opportunity to exhibit your knowledge and technical abilities in a unique environment, then look no further! In this role, you will be challenged to drive the success of Evolus in an effort to build a brand like no other Essential duties and responsibilities where you'll make the biggest impact…
- Key responsibilities include, but are not limited to:
- Perform product disposition
- Complaint handling
- Investigate deviations and determine corrective actions/preventive actions to address the root cause
- Assess and approve change control records
- Create and/or revise procedures, specifications, and processes for continuous improvement
- Managing the device QMS
- Evaluate device complaints and assess each case for reportability to ensure regulatory compliance
- Collaborate with other departments, including Customer Experience, Medical Affairs, and Safety, to obtain missing complaint information
- Classify device complaints and coordinate communication with external partners to support complaint investigation closure
- Assess all device complaint files for completeness and reporting to the US FDA as per the targeted timeframes
- Submit complete and accurate MedWatch forms to the US FDA
- Monitor aged device complaints and ensure closure
- Trend medical device complaint data and present during periodic quality meetings
- Manage relationships with vendors and partners
- Support both internal and external audits
- Be adaptable and open to taking on Ad-Hoc projects and tasks as they arise
- Office Location - Newport Beach (hybrid onsite Tuesday, Wednesday, and Thursday)
- Other duties as assigned
- Bachelor’s degree in a scientific, technical, or related field
- 13+ years of experience in the medical device industry
- Strong understanding of US FDA 21 CFR 803/806/820 and global medical device regulations
- Proficiency in Microsoft Office Suite and Smartsheets
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