Quality Systems Specialist

QUALITY SYSTEMS SPECIALIST I

THE COMPANY: 

Element Science, Inc. is a medical device and digital health company focused on developing solutions at the intersection of clinical-grade wearables, machine learning algorithms, and lifesaving therapies in order to address leading causes of death and hospitalization in patients with heart disease, primarily as they transition from the hospital-to-home. By putting the needs of patients and physicians first, our personalized digital devices, which are designed for function, comfort, and ease-of-use, aim to redefine the paradigm of care for these patients.  Our first product, a wearable patch defibrillator, is initially targeted at treating the more than 500,000 patients in the US with an elevated temporary risk of potentially experiencing a lethal heart rhythm.  Based in San Francisco, our funders include Third Rock Ventures, Google Ventures, Deerfield Healthcare, Qiming Venture Partners USA, 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.

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