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Quality Engineer III

Penumbra is a global healthcare company focused on innovative therapies, designing, developing, manufacturing, and marketing novel products to address challenging medical conditions in markets with significant unmet need.
Alameda, CA, USA
$109,760 - $145,920
Mid-Level Software Engineer
In-Person
3+ years of experience
Healthcare
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Description For Quality Engineer III

As a Quality Engineer III at Penumbra, you'll have the opportunity to make a significant impact on life-saving medical devices. You'll independently support Commercial Operations to ensure high-quality manufacturing of Class II/III interventional medical devices. This role involves working with advanced problems, analyzing situations, and exercising good judgment to determine appropriate quality actions. You'll collaborate with teams to communicate and implement quality objectives.

Key responsibilities include:

  • Supporting Commercial Operations and Manufacturing activities
  • Performing failure analyses and defect investigations
  • Executing Continuous Improvement efforts
  • Supporting supplier activities
  • Interfacing with other engineering departments and suppliers on quality issues
  • Collaborating on manufacturing documentation development
  • Designing and improving Test Methods and Equipment
  • Providing guidance to junior Quality Engineers

The ideal candidate will have:

  • Associate's or Bachelor's degree in Engineering, Life Science, or related field
  • 3+ years of quality engineering experience, preferably in medical devices
  • Familiarity with QSR, ISO, and applicable regulations
  • Excellent communication skills and leadership abilities
  • Proficiency in MS Office suite

Penumbra offers a collaborative environment, the chance to revolutionize treatment for devastating diseases, and a generous benefits package including health insurance, 401(k) with employer match, paid parental leave, and vacation time.

Join Penumbra in Alameda, CA, and be part of a team making a real difference in healthcare innovation!

Last updated 6 months ago

Responsibilities For Quality Engineer III

  • Support Commercial Operations and Manufacturing activities
  • Perform failure analyses and defect investigations
  • Execute and collaborate on Continuous Improvement efforts
  • Support supplier activities such as Second Source Qualifications, Supplier Changes, and SCARs
  • Interface with other engineering departments and suppliers on quality related issues
  • Collaborate in the development of manufacturing documentation
  • Design, improve and support Test Methods, Testing Equipment and TMVs
  • Recommend revisions to specifications, acceptance criteria, and manufacturing documentation
  • Provide guidance to junior Quality Engineers
  • Ensure compliance with Quality System, regulations, standards, and procedures

Requirements For Quality Engineer III

  • Associate's or Bachelor's degree in Engineering, Life Science, or related field
  • 3+ years of quality engineering or relevant experience, preferably in medical devices
  • Familiarity with QSR, ISO, and other applicable regulations and laws
  • Excellent verbal, written, and interpersonal communication skills
  • Proficiency with MS Word, Excel, and PowerPoint

Benefits For Quality Engineer III

401k
Dental Insurance
Medical Insurance
Parental Leave
Vision Insurance
  • Medical insurance
  • Dental insurance
  • Vision insurance
  • Life insurance
  • AD&D insurance
  • Short and long-term disability insurance
  • 401(k) with employer match
  • Employee stock purchase plan
  • Paid parental leave
  • Eleven paid company holidays per year
  • Minimum of fifteen days of accrued vacation per year, increasing with tenure
  • Paid sick time

Interested in this job?