Quality Engineer II: Medical Devices & QMS Excellence

Penumbrainc; Alameda (CA); On-site; USD 95,000 - 127,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

AD&D insurance

Disability insurance

401(k) with employer match

Paid parental leave

Eleven paid company holidays per year

Vacation days (15+ per year)

Paid sick time

Job summary

Penumbrainc in Alameda, CA is seeking a Quality Engineer II responsible for developing and implementing quality system elements to ensure product quality and regulatory compliance. You will collaborate with multiple teams to qualify products and improve testing methodologies.

The role requires 2+ years in quality engineering within a regulated environment, familiarity with QSR/ISO, and strong communication skills. On-site position with competitive compensation and comprehensive benefits.

Qualifications

• Minimum education: Associate’s or Bachelor's in Engineering or related field with 2+ years of quality engineering experience in a regulated environment.
• Familiarity with QSR, ISO and other applicable regulations.
• Experience with electronic devices and PCBs recommended.
• Excellent verbal and written communication skills; proficient with MS Office.

Responsibilities

• Collaborate in development and qualification activities for new and existing products.
• Develop testing and inspection methodologies and documentation.
• Design and install QC process sampling systems and statistical techniques.
• Perform failure analyses and defect investigations.
• Interface with engineering, customers, and suppliers on quality issues.

Skills

Quality engineering

Regulatory compliance

PCBAs

Technical communication

Education

Bachelor's degree in Engineering

Associate’s degree in Engineering

Tools

MS Word

MS Excel

MS PowerPoint

Job description

Penumbrainc in Alameda, CA is seeking a Quality Engineer II responsible for developing and implementing quality system elements to ensure product quality and regulatory compliance. You will collaborate with multiple teams to qualify products and improve testing methodologies.

The role requires 2+ years in quality engineering within a regulated environment, familiarity with QSR/ISO, and strong communication skills. On-site position with competitive compensation and comprehensive benefits.