Full-Time

Sr. Quality Engineer

Confirmed live in the last 24 hours

Outset Medical

Outset Medical

501-1,000 employees

Dialysis treatment solutions and training programs

Healthcare

Compensation Overview

$135k - $183kAnnually

Senior

San Jose, CA, USA

Category
QA & Testing
Quality Assurance
Requirements
  • Bachelor’s degree in Electrical or Mechanical Engineering (or similar) required.
  • Minimum of 4+ years of hands on experience with quality engineering manufacturing and field support.
  • Prior experiences in a regulated environment, preferably medical device.
  • Familiarity with use of mechanical and electrical test equipment.
  • Basic statistical analysis skills and proficiency with MS Office.
  • Ability to work effectively in a fast paced and dynamic environment.
  • Leadership and interpersonal skills to develop and manage good working relationships with internal departments (manufacturing, receiving, purchasing, product development, and regulatory), contractors, and suppliers.
  • Strong written and verbal communication skills.
Responsibilities
  • Investigate causes of quality problems identified from field complaints, field service records, manufacturing, final QC inspection, incoming inspection, and suppliers.
  • Manage the root cause analysis and corrective actions process of supplier quality issues.
  • Support departmental effort in CAPA investigation and completion.
  • Collect, analyze, trend, and communicate quality data throughout the organization.
  • Identify validation and/or verification required for design changes.
  • Support manufacturing, new product development, and regulatory to ensure compliance with all internal and external requirements; represent quality interests and concerns on project teams.
  • Implement and qualify software tools related to product or process changes.
  • Identify product quality and quality system improvement opportunities and drive procedure updates when required.
  • Carry out supplier qualification or surveillance audits, with supplier support and supplier advanced product quality planning. Write associated audit reports for distribution to senior management.
  • Support new product launches and/or manufacturing transfers and/or sourcing projects to ensure suppliers can deliver to the required quality standards.

Outset Medical improves dialysis treatment by offering the Tablo system, which integrates with electronic medical record (EMR) platforms to streamline workflows and manage patient data effectively. They provide educational programs and hands-on training for dialysis professionals, including a Vascular Access Program to enhance staff skills and a Bridge Program to support facilities transitioning to in-house dialysis services. The company aims to enhance the quality of care for dialysis patients in hospitals, outpatient clinics, and home care settings. Outset Medical stands out by combining their product with comprehensive training and support.

Company Stage

IPO

Total Funding

$378.4M

Headquarters

San Jose, California

Founded

2010

Growth & Insights
Headcount

6 month growth

-9%

1 year growth

-15%

2 year growth

-6%
Simplify Jobs

Simplify's Take

What believers are saying

  • Partnership with U.S. Renal Care expands home dialysis market reach.
  • FDA clearance of TabloCart enhances system flexibility and usability.
  • $125M Series E funding boosts R&D and market expansion efforts.

What critics are saying

  • Class action lawsuits may lead to financial liabilities and reputational damage.
  • Regulatory challenges can delay product rollouts, affecting supply chains.

What makes Outset Medical unique

  • Tablo system integrates with EMR for streamlined dialysis workflows.
  • Vascular Access Program enhances staff expertise in cannulation and vascular access management.
  • Bridge Program supports facilities transitioning to in-house dialysis services.

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Benefits

Medical, dental, & vision

Life Insurance/AD&D

FSA & HSA

401k

Parental leave

Pet insurance

Tuition reimbursement

PTO

Company events