Quality Engineer II — Medical Device QA & Process Improvement

Penumbra, Inc.; Alameda (CA); On-site; USD 95,000 - 127,000; Full time

Benefits offered by this job

Medical, dental, vision

401(k) with employer match

Paid parental leave

11 company holidays

Accrued vacation

Paid sick time

Job summary

Penumbra, Inc. is seeking a Quality Engineer II to develop and implement quality system elements ensuring high-quality products and regulatory compliance.

The role involves collaborating with multiple teams on testing, inspection methodology, and QC processes to sustain product integrity. Candidates should have 2+ years in quality engineering within a medical device or regulated environment, strong communication skills, and proficiency with common MS Office tools.

Qualifications

• Associate’s or Bachelor’s degree in Engineering, Life Science, or related field with 2+ years of quality engineering experience.
• Experience in a medical devices regulated environment preferred.
• Familiarity with QSR, ISO and applicable regulations required.
• Excellent verbal, written and interpersonal communication skills.
• Proficiency with MS Word, Excel and PowerPoint.

Responsibilities

• Collaborate in development and qualification activities for products.
• Develop testing/inspection methodologies and documentation.
• Assist on Quality Objective teams and QC process sampling systems.
• Design/install inspection/testing mechanisms and equipment.
• Perform failure analyses and defect investigations.
• Interface with engineering, customers and suppliers on quality issues.
• Adhere to QMS and applicable regulations and procedures.

Skills

Quality engineering

Regulatory compliance

Problem solving

Interpersonal communication

Education

Bachelor’s or Associate’s degree in Engineering or Life Sciences

Tools

MS Word

MS Excel

PowerPoint

Job description

Penumbra, Inc. is seeking a Quality Engineer II to develop and implement quality system elements ensuring high-quality products and regulatory compliance.

The role involves collaborating with multiple teams on testing, inspection methodology, and QC processes to sustain product integrity. Candidates should have 2+ years in quality engineering within a medical device or regulated environment, strong communication skills, and proficiency with common MS Office tools.