Sr. Quality Engineer

Penumbra-posted 9 months ago
$113,000 - $157,000/Yr
Full-time • Senior
Roseville, CA
Professional, Scientific, and Technical Services
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As a Senior Quality Engineer at Penumbra, you will participate in all aspects of process development, supplier development and manufacturing in order to ensure the highest level of quality in new and existing products, and their compliance to applicable regulations and standards. You will apply your passion for detailed analysis to identify problems and determine the appropriate course of action. You will be looked to for communicating quality objectives and building a culture of quality throughout the company.

  • Represent Quality Engineering on cross-functional teams - interfacing among multiple departments and teams such as Manufacturing, QC, R D, Regulatory Affairs, Operations/Planning, and Marketing.
  • Evaluate, analyze, and continuously improve manufacturing processes, quality controls, and engineering systems for assigned product lines.
  • Own or review Engineering Change Orders on assigned projects and product lines.
  • Plan, design, and implement test/inspection methods, including test/inspection equipment, to achieve product quality control objectives.
  • Partner with suppliers to continually improve technical processes, reliability, and quality controls to meet Penumbra's quality standards.
  • Take the lead on risk analysis and documentation.
  • Lead or participate in project teams - coordinating the quality efforts to meet project objectives.
  • Plan, schedule, and execute engineering project work to meet business and quality objectives.
  • Provide leadership and guidance to ensure assigned projects and product lines are compliant with the quality system and regulations.
  • Lead nonconforming report investigations and recommend appropriate corrective actions.
  • Identify the need for Corrective Action Preventative Action (CAPA). Initiate, implement, and close CAPAs.
  • Design experiments and tests, and apply statistical rationale to analyze, and interpret engineering test data.
  • Provide leadership and mentoring to more junior staff. May supervise junior engineers.
  • Bachelor's degree in Engineering, a Life Science or related field with 5+ years of relevant experience, including experience in Quality Assurance and ISO, or an equivalent combination of education and experience.
  • Advanced degree preferred.
  • Experience in auditing, design review, sterilization, project management, and/or product development is highly desired.
  • Medical, dental, vision, life, AD&D, short and long-term disability insurance.
  • 401(k) with employer match.
  • Employee stock purchase plan.
  • Paid parental leave.
  • Eleven paid company holidays per year.
  • A minimum of fifteen days of accrued vacation per year, which increases with tenure.
  • Paid sick time in compliance with applicable law(s).
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