Quality Systems Specialist II

Element Science, Inc. is a medical device and digital health company redefining how patients with heart disease are monitored and treated as they transition from the hospital to the home. Our mission is to improve outcomes for patients at risk of life-threatening cardiac events through innovative solutions at the intersection of clinical-grade wearables, advanced algorithms, and therapy delivery. We are entering an exciting phase of growth as we move from development into early commercialization. Our approach combines hardware, software, and services to deliver a more personalized and seamless patient experience—designed with both patients and clinicians in mind. Our product, a wearable patch defibrillator, is designed for patients with a temporary elevated risk of sudden cardiac arrest, addressing a significant and underserved population of over 500,000 patients in the U.S. By focusing on comfort, usability, and clinical effectiveness, we aim to transform the standard of care during this critical period. Headquartered in the San Francisco Bay Area, Element Science is backed by leading healthcare and technology investors, including Third Rock Ventures, GV (Google Ventures), Deerfield Healthcare, Cormorant Asset Management, and Invus Opportunities. SUMMARY OF ROLE: We are looking for a Quality Systems Specialist II with passion for creating devices that save lives. The Quality Systems Specialist II works closely with cross-functional teams to assist in key quality initiatives, including Complaint Management, Change Control, NCR (Non-Conformance Report) Management, CAPA (Corrective and Preventive Actions), and more. This position will play a vital role in guiding teams, ensuring compliance with industry regulations, and supporting various quality improvement efforts. If you are passionate about ensuring product quality and regulatory compliance, we would love to talk to you. RESPONSIBILITIES: Support the CAPA processes by facilitating investigations, tracking progress, and ensuring that corrective and preventive actions are implemented effectively. Perform investigations for Quality-owned CAPAs, analyzing root causes, identifying corrective and preventive actions. Work closely with teams including Manufacturing Engineering, Quality Engineering, Regulatory Affairs, R&D, and Production to support quality initiatives and ensure compliance with QMS requirements. Review ECOs as a Quality SME and provide feedback and guidance on the impact of changes and help ensure changes are implemented in compliance with internal procedures and regulatory standards. Assist in the review, routing, and approval of QMS documentation, ensuring all records are accurate, complete, and meet regulatory and quality standards. Follow up with stakeholders to ensure timely approval and completion of documentation tasks. Provide guidance and support to team members and peers in understanding and following QMS processes. Assist with training activities and contribute to a culture of continuous learning and improvement. Collect, analyze, and report on key quality metrics related to complaints, NCRs, CAPAs, and other QMS processes. Help track trends and provide insights to identify areas for process improvements. Support internal and external audits, ensuring compliance with ISO 13485, QMSR, and other applicable regulations. Support the resolution of audit findings and help implement corrective actions. Support DME/CHAP quality documentation requirements as applicable to the company's distribution model. Assist in Post-Market Surveillance activities, tracking and analyzing product performance data to identify potential quality issues or trends that require attention. Lead or participate in various quality improvement initiatives, helping to identify opportunities for process optimization and supporting the implementation of changes to enhance quality performance. Other tasks as assigned by the management. QUALIFICATIONS: Bachelor's degree in a scientific or engineering discipline or related discipline. 3+ years of relevant experience in a Medical Device environment with a focus on Quality Systems Demonstrates strong knowledge of current ISO 13485 standard and QMSR. Strong ability to collaborate with cross-functional teams, providing guidance and input on various quality initiatives. Excellent communication skills (written and verbal), with the ability to clearly explain and assist others with QMS processes and requirements. Strong organizational skills, with the ability to manage multiple tasks, prioritize effectively, and meet deadlines in a fast-paced environment. Experience with Propel or similar eQMS platform strongly preferred. Strong problem-solving and analytical skills, with the ability to interpret data and make informed decisions. Ability to work independently and take ownership of tasks while collaborating with others to meet common goals. Prior experience preparing for or leading an internal, external, or regulatory audit. BENEFITS: Element Science offers a very competitive salary and benefits package including, but not limited to: Stock Options 90% employer-paid medical, dental, and vision insurance Company-paid Basic Life Insurance 401(k) retirement plan (Traditional and Roth) Competitive Paid Time Off Paid Holidays FSA (Flexible Spending Accounts) HSA (Health Savings Account) Employee Assistance Program through PEO The salary for this exempt-level position will be based on experience and qualifications within an established pay range. Pay range: $87,000 - $100,000 + Annual Bonus Element Science is an Equal Opportunity Employer. All candidates will be evaluated on the basis of their qualifications for the job in question. We do not base our employment decision on an employee's or applicant's race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), political affiliation, military service, or other non-merit-based factors prohibited by local, state, or federal law. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.We are not able to sponsor individuals for employment visas for this job. At this time, we are unable to offer relocation assistance at Element Science. #J-18808-Ljbffr Regulatory Jobs