Sr. Quality Engineer

Global healthcare company focused on innovative therapies, designing and manufacturing novel products for challenging medical conditions in markets with significant unmet need.
$113,000 - $157,000
Quality
Senior Software Engineer
In-Person
1,000 - 5,000 Employees
5+ years of experience
Healthcare · Biotech

Description For Sr. Quality Engineer

Penumbra, a leading global healthcare company headquartered in Alameda, California, is seeking a Senior Quality Engineer to join their innovative team. This role offers an exciting opportunity to work at the intersection of healthcare innovation and quality assurance, focusing on developing and maintaining high-quality standards for medical devices that address challenging medical conditions.

The position involves comprehensive responsibility for quality assurance across multiple aspects of the product lifecycle. As a Senior Quality Engineer, you'll be integral to ensuring product compliance with regulatory standards while working closely with cross-functional teams including Manufacturing, QC, R&D, and Regulatory Affairs. The role demands expertise in quality control systems, risk analysis, and process improvement, with opportunities to lead investigations and implement corrective actions.

The ideal candidate will bring 5+ years of relevant experience, with a strong background in quality assurance and ISO standards. They should possess a Bachelor's degree in Engineering or Life Sciences, though an advanced degree is preferred. The role offers competitive compensation ranging from $113,000 to $157,000 annually, along with comprehensive benefits including medical, dental, vision coverage, and 401(k) with employer match.

Working at Penumbra means joining a company at the forefront of medical device innovation, with a strong focus on addressing unmet medical needs globally. The company culture emphasizes collaborative teamwork, continuous learning, and professional growth. This role provides an excellent opportunity for someone passionate about quality engineering to make a significant impact on healthcare outcomes while working with cutting-edge medical technologies.

The position is based in the San Francisco Bay Area, offering the chance to work in one of the world's leading healthcare innovation hubs. The role includes a mix of office, laboratory, and cleanroom environments, with minimal travel requirements (0-10%). Penumbra's commitment to diversity and inclusion, combined with their comprehensive benefits package and growth opportunities, makes this an attractive position for quality engineering professionals looking to advance their careers in medical device quality assurance.

Last updated 13 days ago

Responsibilities For Sr. Quality Engineer

  • Represent Quality Engineering on cross-functional teams
  • Evaluate, analyze, and continuously improve manufacturing processes
  • Own or review Engineering Change Orders
  • Plan, design, and implement test/inspection methods
  • Partner with suppliers to improve technical processes
  • Lead risk analysis and documentation
  • Lead nonconforming report investigations
  • Identify and manage Corrective Action Preventative Action (CAPA)
  • Design experiments and tests
  • Provide leadership and mentoring to junior staff

Requirements For Sr. Quality Engineer

  • Bachelor's degree in Engineering, Life Science or related field
  • 5+ years of relevant experience including Quality Assurance and ISO
  • Advanced degree preferred
  • Experience in auditing, design review, sterilization, project management
  • Knowledge of QSR, ISO 13485 regulations
  • Knowledge of sterilization, biocompatibility standards
  • Working knowledge of data analysis and scientific methods
  • ASQ CQE preferred

Benefits For Sr. Quality Engineer

Medical Insurance
Dental Insurance
Vision Insurance
401k
Parental Leave
  • Medical insurance
  • Dental insurance
  • Vision insurance
  • Life insurance
  • AD&D insurance
  • Short and long-term disability
  • 401(k) with employer match
  • Employee stock purchase plan
  • Paid parental leave
  • 11 paid holidays per year
  • 15+ days of vacation (increases with tenure)
  • Paid sick time

Interested in this job?

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