Quality Systems Specialist II — Medical Device Quality

Job overview

The Quality Systems Specialist II is an onsite role in Redwood City, California. The stated annual pay range is $87,000–$100,000, plus an annual bonus. Element Science develops a wearable patch defibrillator and digital health solutions for patients at risk of life-threatening cardiac events. The specialist supports quality-system processes and cross-functional quality initiatives, helping ensure regulatory compliance and improve product quality. The work spans CAPA, complaints, change control, non-conformance management, documentation, audits, metrics, and post-market surveillance as the company moves toward early commercialization.

What you'll do

• Facilitate CAPA investigations and track corrective and preventive actions
• investigate Quality-owned CAPAs and analyze root causes
• collaborate with Manufacturing Engineering, Quality Engineering, Regulatory Affairs, R&D, and Production
• review engineering change orders as a Quality subject-matter expert
• route and approve QMS documentation
• support training and process guidance
• analyze quality metrics and trends
• support audits and resolution of findings
• support applicable DME/CHAP documentation
• assist with post-market surveillance
• participate in quality improvement initiatives.

What we're looking for

Skills & competencies

quality systems specialist ii

medical device quality

redwood city ca

element science

$87k–$100k/year

annual bonus

capa

iso 13485

qmsr

change control

audit support

post-market surveillance

Work arrangement

• Weekend coverage required

Benefits & perks

• Stock options
• 90% employer-paid medical, dental, and vision insurance
• company-paid basic life insurance
• 401(k)
• paid time off and holidays
• FSA
• HSA
• employee assistance program.

Why this role

Requires a bachelor’s degree in a scientific, engineering, or related discipline and 3+ years of medical-device quality-systems experience. Knowledge of ISO 13485 and QMSR is required; Propel or a similar eQMS platform is strongly preferred. Visa sponsorship and relocation assistance are not available.

About the employer

Element Science is hiring for this role. Industry: Electromedical and Electrotherapeutic Apparatus Manufacturing. Sector: 33.