Quality Engineer II — Medical Devices, QC & QMS (Equity)

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

Benefits offered by this job

Medical insurance

401(k) with employer match

Paid holidays and vacation

Job summary

Penumbra, Inc. seeks a Quality Engineer II to develop and implement quality system elements ensuring high product quality and regulatory compliance. The role involves collaboration across departments to improve testing, inspections, and QC processes while adhering to the QMS.

Minimum 2+ years of quality engineering experience in regulated environments is preferred. The position is based in Alameda, CA with a comprehensive benefits package and equity opportunities where applicable.

Qualifications

• 2+ years of quality engineering or relevant experience in regulated environments.
• Familiarity with QSR, ISO regulations and related laws.
• Experience with electronic devices or PCBs.
• Excellent verbal, written, and interpersonal communication skills.
• Proficiency with MS Word, Excel and PowerPoint.

Responsibilities

• Collaborate in development and qualification activities for new and existing products.
• Collaborate on testing and inspection methodologies and documentation.
• Collaborate on Quality Objective teams.
• Design and install QC process sampling systems, procedures, and statistical techniques.
• Design or specify inspection and testing mechanisms and equipment.
• Perform failure analyses and defect investigations.
• Interface with other engineering departments, customers, and suppliers on quality issues.
• Adhere to the QMS and applicable regulations, standards, and procedures.

Skills

Verbal communication

Written communication

Interpersonal communication

Education

Bachelor's/Associate degree in Engineering or Life Science

Tools

MS Word

Excel

PowerPoint

Job description

Penumbra, Inc. seeks a Quality Engineer II to develop and implement quality system elements ensuring high product quality and regulatory compliance. The role involves collaboration across departments to improve testing, inspections, and QC processes while adhering to the QMS.

Minimum 2+ years of quality engineering experience in regulated environments is preferred. The position is based in Alameda, CA with a comprehensive benefits package and equity opportunities where applicable.