Full-Time

Sr. Quality Systems Specialist

Confirmed live in the last 24 hours

Element Science

Element Science

51-200 employees

Develops wearable defibrillator for cardiac arrest

Biotechnology
Healthcare

Compensation Overview

$100k - $125kAnnually

+ Annual Bonus + Stock Options

Senior

No H1B Sponsorship

San Carlos, CA, USA

No relocation assistance available.

Category
Healthcare Administration & Support
Medical, Clinical & Veterinary
Requirements
  • 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.
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.

Element Science focuses on developing health technology aimed at preventing sudden cardiac arrest. Its main product, Jewel®, is a wearable defibrillator that offers continuous monitoring and protection for individuals at risk. Although Jewel® is not yet available for purchase in the U.S., it represents a significant advancement in medical devices. The company targets millions of people worldwide who are at risk of sudden cardiac arrest, planning to sell the device to individuals, healthcare providers, and insurance companies once it is commercially launched. Element Science distinguishes itself from competitors by prioritizing diversity, equity, inclusion, and belonging within its workforce, reflecting its commitment to positive societal impact. The company's goal is to enhance the lives of those at risk of cardiac events while also fostering a supportive and inclusive work environment.

Company Stage

Series C

Total Funding

$178.1M

Headquarters

San Francisco, California

Founded

2013

Growth & Insights
Headcount

6 month growth

7%

1 year growth

8%

2 year growth

12%
Simplify Jobs

Simplify's Take

What believers are saying

  • The global wearable medical device market is projected to grow at a 23.1% CAGR.
  • Element Science raised $145.6 million in Series C funding, supporting product development.
  • FDA's expedited approval process for digital health technologies could benefit Element Science.

What critics are saying

  • Delay in FDA approval could hinder U.S. market entry for the Jewel® defibrillator.
  • Intensifying competition from companies like Zoll Medical may impact Element Science's market share.
  • Supply chain disruptions could delay Jewel® device production and distribution.

What makes Element Science unique

  • Element Science's Jewel® defibrillator offers 24/7 protection for high-risk cardiovascular patients.
  • The company integrates machine learning with clinical-grade wearables for enhanced patient monitoring.
  • Element Science emphasizes DEIB, reflecting a commitment to a diverse and inclusive workforce.

Help us improve and share your feedback! Did you find this helpful?

Benefits

Stock Options

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance

401(k) Retirement Plan

Unlimited Paid Time Off

Paid Vacation

Paid Holidays

FSA (Flexible Spending Accounts)

HSA (Health Savings Account)

Employee Assistance Program through PEO