INACTIVE
Full-Time
Quality Systems Specialist
Posted on 4/5/2024
Develops wearable cardioverter defibrillators
Data & Analytics
Hardware
Compensation Overview
$87,000 - $100,000Annually
+ Annual Bonus + Stock Options
Junior
San Carlos, CA, USA
Required Skills
Communications
Requirements
- 1 year of relevant experience in Medical Device environment and Quality Systems.
- Working knowledge of current ISO 13485 standard and QSR.
- Bachelor's degree in Science or Engineering preferred.
- Ability to work in a team environment, manage multi-tasking, and discipline in completing tasks on schedule.
- Excellent written and verbal communication skills.
- Strong organizational skills to manage and prioritize multiple tasks while meeting delivery dates.
Responsibilities
- Receive and review complaints related to medical devices.
- Communicate with NCR/CAPA/DA owners to obtain status updates or provide reminders about upcoming due dates.
- Maintain and update NCR/CAPA/DA tracking systems.
- Prioritize routing QMS process documentation for approvals and follow up with approvers if response is not received in a reasonable timeframe.
- Collaborate and communicate cross-functionally with teams including Manufacturing Engineering, Quality Engineering, Regulatory Affairs, R&D, and Production.
- Assist with data compilation for monthly metrics updates.
- Review quality records associated with the QMS process to ensure accuracy with the approved format and standards.
- Ensure customer complaint investigations are complete, accurate, and closed in a timely manner, meeting regulatory requirements.
- Make initial reporting decisions, facilitate investigations, and ensure completeness and consistency of the documentation for complaints.
- Help track and trend complaint data and provide input to product/process risk management.
- Participate in Post-Market Surveillance activities as needed.
- Support management during internal and external audits.
- Support reviewing documents and change orders to ensure quality records documentation accuracy and completeness.
- Support and drive CAPA activities to effectiveness closures.
- Assist or support internal or external audits and drive towards resolutions to ensure compliance with the QSR and ISO standards.
Element Science develops the Jewel Patch Wearable Cardioverter Defibrillator (P-WCD), a medical device that utilizes advanced technology to detect and treat life-threatening heart rhythms, aiming to redefine treatment for sudden cardiac death. The wearable solution addresses leading causes of death and hospitalization due to heart disease, focusing on providing a new approach to managing cardiac conditions using advanced detection and treatment technologies.
Company Stage
Series C
Total Funding
$183.1M
Headquarters
San Francisco, California
Founded
2013
Growth & Insights
Headcount
6 month growth
↑ 11%1 year growth
↑ 16%2 year growth
↑ 70%INACTIVE