Sr. Quality Assurance Manager
Description
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…
- 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
Qualifications and Skills You’ll Bring to the Team…
- 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
Compensation & Total Rewards
This is an Exempt position. The expected pay range for this position is $163,000 to $190,000. Your actual base salary will be determined on a case-by-case basis and may vary based on a number of considerations, including but not limited to role-relevant knowledge and skills, experience, education, geographic location, certifications, and more.
We offer more than just a paycheck, and your base salary is just the start! Stay happy and healthy with our competitive suite of medical, dental and vision benefits to help you feel your best and be your best. We also provide those benefits you shouldn’t have to worry about, from employer covered life insurance to short-term disability. Take advantage of the 401k match offered by Evolus and let us invest in your future. You may also be eligible for new hire equity and long-term incentives in the form of RSUs, stock options, and/or discretionary bonuses. We offer mental health and wellbeing resources for you to develop skills to find your calm, boost your confidence, and show up as your best self in work and life. Travel or relax and come back feeling refreshed with our flexible paid time off program for exempt employees and a paid time off accrual plan for non-exempt employees. Did we mention the holiday soft closure between the Christmas and New Years holidays? We have that, too. Additional perks include regularly catered team meals at our Evolus Headquarters, a fully stocked kitchen (Kombucha & Coffee included), and the opportunity to join an organization where our values of Grit, Impact, Fun, and Transparency are displayed daily.
Evolus takes pride in being a company on the forefront of innovation, while being committed to conducting its business with the highest degrees of integrity, professionalism, and social responsibility. We are also committed to complying with all laws and regulations that apply to our business. Employee welfare is no different. Here at Evolus, we don’t just work together, we’ve built a culture of inclusion! Because of this, you’ll find yourself immersed in an environment that not only promotes respect, collaboration and team building, but a community too. And that’s just the tip of the iceberg. Join our team and see for yourself! EOE M/F/D/V. For more information, please visit our website at www.evolus.com or reach out to [email protected].
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