# Senior Quality Engineer at Element Science

> United States · Senior · QA / Test · open. Source: https://alderhq.app/jobs/greenhouse%3Aelementscience%3A5252575007 (read 2026-11-09).

## Facts (observed)

- Company: [Element Science](https://alderhq.app/companies/element-science)
- Location text: Redwood City; Element Science - Redwood City, CA
- Where it can be done from (inferred): United States (evidence: "Location: Redwood City; Element Science - Redwood City, CA")
- Posted: 2026-10-01 (39 days ago)
- First seen by alder: 2026-11-07 · last verified: 2026-11-07
- Reposted: 0 times · edited: 0 times
- Apply on the employer's site: https://elementscience.com/careers/?gh_jid=5252575007

## Pay and sponsorship

- Posted pay: not posted
- Market band for similar posted roles (SF Bay Area, n 40): p25 $161k, median $188k, p75 $203k

## Description (the employer's text)

Element Science, Inc. is a medical device and digital health company redefining how patients with heart disease are monitored and treated as they transition from the hospital to the home. Our mission is to improve outcomes for patients at risk of life-threatening cardiac events through innovative solutions at the intersection of clinical-grade wearables, advanced algorithms, and therapy delivery.

We are entering an exciting phase of growth as we move from development into early commercialization. Our approach combines hardware, software, and services to deliver a more personalized and seamless patient experience—designed with both patients and clinicians in mind. Our product, a wearable patch defibrillator, is designed for patients with a temporary elevated risk of sudden cardiac arrest, addressing a significant and underserved population of over 500,000 patients in the U.S. By focusing on comfort, usability, and clinical effectiveness, we aim to transform the standard of care during this critical period. Headquartered in the San Francisco Bay Area, Element Science is backed by leading healthcare and technology investors, including Third Rock Ventures, GV (Google Ventures), Deerfield Healthcare, Cormorant Asset Management, and Invus Opportunities.

SUMMARY OF ROLE:

Element Science is seeking a Sr. Quality Engineer to support the ongoing quality, reliability, and continuous improvement of our life-saving medical device technology. This role provides Quality Engineering support across the commercial product life cycle and leads the supplier quality program. It partners closely with Engineering, Manufacturing, Supplier Quality, Operations, Supply Chain and other cross-functional teams to ensure products and purchased components continue to meet quality, safety, performance, and regulatory requirements throughout the commercial product lifecycle.

The Sr. Quality Engineer will provide Quality Engineering support for product and process changes, nonconformances, CAPAs, complaints, supplier qualification and performance, risk management, and verification and validation activities. This role will partner with manufacturing on process capability and provide Quality oversight and approval to those activities.The ideal candidate brings strong technical problem-solving skills, sound quality judgment, and a collaborative, hands-on approach to identifying root causes and driving sustainable improvements.

RESPONSIBILITIES:

### Sustaining Quality

- Serve as the Quality Engineering partner for sustaining engineering and post-market product activities, ensuring continued compliance with applicable quality and regulatory requirements.
- Provide Quality oversight for product, component, manufacturing, supplier, and design changes, including assessment of verification and validation requirements.
- Support nonconformance, complaint investigation and CAPA activities, including root cause analysis, risk assessment, corrective actions, and effectiveness verification.
- Partner with Engineering and Operations to investigate product and manufacturing issues and implement sustainable corrective and preventive solutions.
- Maintain and update Risk Management Files in accordance with ISO 14971, incorporating post-market information, product changes, complaints, and identified risks.
- Analyze quality and product performance metrics to identify trends and drive systemic quality and reliability improvements.
- Provide technical Quality expertise for electrical and electromechanical product issues and changes.
### Supplier Quality

- Responsible for supplier quality programs including supplier evaluation, selection, qualification, re-qualification and maintenance of the Approved Supplier List (ASL).
- Plan and perform onsite and remote supplier audits to assess compliance with ISO 13485, regulatory standards, and internal requirements.
- Establish and maintain supplier quality agreements.
- Monitor supplier quality performance through scorecards and periodic quality reviews, including Supplier Corrective Action Requests (SCARs) and drive them to closure

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Data: alder (https://alderhq.app). Cite https://alderhq.app/jobs/greenhouse%3Aelementscience%3A5252575007 and the date you read it. Observed facts come from the employer's own listing; location reach, level, family and skills are inferences.