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Senior Quality Engineer
Confirmed live in the last 24 hours
San Jose, CA, USA
Experience Level
  • 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
  • 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
  • Support new product launches and/or manufacturing transfers and/or sourcing projects to ensure suppliers can deliver to the required quality standards
Desired Qualifications
  • 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
Outset Medical

501-1,000 employees

Dialysis medial equipment manufacturer
Company Overview
Outset Medical is on a mission to transform the dialysis experience – one of the largest, most expensive, and stagnant areas of healthcare. The company is focused on creating change, driving widespread adoption of new technology, and delivering on the promise of an improved experience for patients and lower cost of care for healthcare providers.
  • Medical, dental, & vision
  • Life Insurance/AD&D
  • FSA & HSA
  • 401k
  • Parental leave
  • Pet insurance
  • Tuition reimbursement
  • PTO
  • Company events
Company Core Values
  • Farther
  • Faster
  • Together