SENIOR QUALITY ASSURANCE SPECIALIST

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 seeking a passionate and experienced Senior Quality Systems Specialist to join our team in creating life-saving medical devices. In this role, you will play a critical part in maintaining and enhancing our Quality System by overseeing key functions such as:

• Document and ECO review
• Training activities
• Change control
• Internal audits
• Complaint analysis
• CAPA management

If you have a strong background and proven expertise in managing these Quality System elements and are committed to excellence, we’d love to connect with you!

RESPONSIBILITIES:

• Performs at a senior level of Quality Assurance tasks to ensure quality system compliance with applicable regulatory requirements.
• Leads in developing and improving Standard Operating Procedures and/or Work Instruction as part of the Quality System procedure.
• Responsible for reviewing QMS documentation (e.g., CAPAs, NCRs, Complaints, and change orders) to ensure quality records documentation accuracy and completeness.
• Drives Quality System activities, including process and procedure changes, and ensures that the performance and quality of services conform to established internal and external standards and guidelines.
• Works directly with internal clients with assistance from management and/or more senior level investigators to ensure follow-up of quality issues.
• Responsible for Post Market Surveillance activities and compliance.
• Facilitate MDR Committee for reportable events and completes Health Hazard Evaluation (HHE) and Health Risk Assessment (HRAs) in a timely manner.
• Lead meetings with appropriate departments for specific customer complaint issues, determination and resolution of root causes for complaints.
• Provides expertise and guidance in interpreting policies, regulatory and governmental regulations, and internal regulations to assure compliance.
• Provide training to other employees as necessary on the company’s QM processes, as well as to provide expertise and guidance to other team members.
• Assist or support internal or external audits and drive towards resolutions to ensure compliance with the QSR and ISO standards.
• Participates in cross-functional meetings with internal and external parties as required.
• Supports management review process through development and generation of quality system metrics and generate monthly data as needed. Assist the management in creating QMR presentation slides.
• Other tasks as assigned by management.

QUALIFICATIONS:

• Bachelor’s degree in a scientific or engineering discipline, mechanical, electrical or software engineering preferred.
• 5+ years experience in the medical device industry with 4+ years in a commercial environment.
• Previous experience with PMS & MDR Reporting via FDA portal
• Knowledge of FDA 21 CFR 820,21 CFR 803, and ISO 13485.
• Experience working in the medical device industry, preferably Class III.
• Strong communication and organization skills required.
• Accuracy, attention to detail, and thoroughness.
• Proficiency required with Microsoft applications.
• Multidisciplinary experience in QMS processes (e.g., CAPAs, NCRs, complaints)
• Strong leadership abilities and ability to train or provide guidance to other team members

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: $100,000 - $125,000 + Annual Bonus + Stock Options