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 with passion for creating devices that save lives. The Quality Assurance Specialist filling this role will be supporting various elements of the Quality System such as Complaint management, Training activities, Change Control, NCR management, and CAPA management. If you have a proven track record of handling and managing those Quality System elements, we would love to talk to you.

RESPONSIBILITIES:

• Receive and review complaints related to medical devices.
• Communicates with NCR/CAPA/DA owners to obtain status updates or provide remindersabout upcoming due dates.
• Maintains and updates NCR/CAPA/DA tracking systems.
• Prioritizes routing QMS process documentation for approvals. Follows up with approvers ifresponse is not received in a reasonable timeframe.
• Collaborates and communicates cross-functionally with teams including, but not limited to,Manufacturing Engineering, Quality Engineering, Regulatory Affairs, R&D and Production.
• Assists with data compilation for monthly metrics updates.
• Receives data requests (charts, graphs, etc.), and implements the changes withguidance/support.
• Reviews quality records associated with the QMS process to ensure accuracy with theapproved format and standards.
• Ensure customer complaint investigations are complete, accurate and closed in a timely manner; includes 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.
• Supports management during internal and external audits, with guidance/support.
• 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 ensurecompliance with the QSR and ISO standards.

QUALIFICATIONS:

• 1 year of relevant experience in Medical Device environment and Quality Systems.
• Demonstrates 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.
• Possesses strong organizational skills to manage and prioritize multiple tasks while meeting delivery dates.

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