Quality Engineer II - Medical Devices & QMS Specialist

Penumbra, Inc.; 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

Short-term disability

Long-term disability

401(k) with employer match

Paid parental leave

Holidays

Vacation days

Paid sick leave

Job summary

Penumbra, Inc. in Alameda, CA is seeking a Quality Engineer II to develop and implement quality system elements ensuring product compliance and high quality. You will work on moderate scope problems, analyze data, and communicate quality objectives across teams.

Responsibilities include collaborating on product development, defining testing methods, performing failure analyses, and maintaining adherence to QMS, QSR, and ISO standards. Strong communication and documentation skills are essential.

Qualifications

• 2+ years of quality engineering experience in a medical devices or regulated environment.
• Familiarity with QSR, ISO and related regulations.
• Experience with electronic devices and PCBAs.
• Strong communication skills.

Responsibilities

• Collaborate on development and qualification activities for products.
• Develop testing and inspection methodologies and documentation.
• Design and install QC sampling systems and statistical techniques.
• Interface with engineering, customers, and suppliers on quality issues.
• Perform failure analyses and defect investigations.
• Audit internal processes and maintain QMS compliance.
• Recommend revisions to specifications.
• Contribute to standard operating procedures.
• Support quality objectives teams.
• Ensure compliance with regulatory requirements.

Skills

Quality engineering

Regulatory awareness

Written and verbal communication

Cross-functional collaboration

Education

Bachelor’s or Associate’s degree in engineering or related field

Tools

MS Word

MS Excel

MS PowerPoint

Job description

Penumbra, Inc. in Alameda, CA is seeking a Quality Engineer II to develop and implement quality system elements ensuring product compliance and high quality. You will work on moderate scope problems, analyze data, and communicate quality objectives across teams.

Responsibilities include collaborating on product development, defining testing methods, performing failure analyses, and maintaining adherence to QMS, QSR, and ISO standards. Strong communication and documentation skills are essential.