Quality Engineer II - Medical Devices, ISO/QMS Focus

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

Benefits offered by this job

Medical, dental and vision coverage

401(k) with employer match

Paid holidays and vacation

Job summary

Penumbra, Inc. is seeking a Quality Engineer II in Alameda, CA to develop and implement quality system elements ensuring product quality and regulatory compliance.

The role involves collaborating across teams to design inspection methods, perform failure analyses, and uphold the QMS in a regulated environment. Minimum education is an associate or bachelor’s in engineering or life sciences with 2+ years in quality engineering.

Qualifications

• 2+ years of quality engineering or relevant experience in a medical device or regulated environment.
• Familiarity with QSR, ISO and related regulations.
• Engineering experience in a manufacturing environment; medical device preferred.
• Experience with electronic devices and PCBAs.
• Excellent verbal, written, and interpersonal communication skills.

Responsibilities

• Collaborate in development and qualification activities for new and existing products.
• Collaborate on testing and inspection methodology and documentation for new and existing products.
• Contribute to Quality Objective teams and projects.
• Design and install QC process sampling systems, procedures, and statistical techniques.
• Interface with other departments, customers, and suppliers on quality issues.

Skills

Quality engineering experience

Communication skills

Regulatory awareness

Education

Associate's or Bachelor's degree in Engineering or Life Science

Tools

MS Word

MS Excel

PowerPoint

Job description

Penumbra, Inc. is seeking a Quality Engineer II in Alameda, CA to develop and implement quality system elements ensuring product quality and regulatory compliance.

The role involves collaborating across teams to design inspection methods, perform failure analyses, and uphold the QMS in a regulated environment. Minimum education is an associate or bachelor’s in engineering or life sciences with 2+ years in quality engineering.