Medical Device Quality Engineer II - Drive Compliance

Penumbra, Inc.; Roseville (CA); On-site; USD 85,000 - 114,000; Full time

Benefits offered by this job

Competitive compensation package

Benefits and equity program

Paid holidays and vacation

Job summary

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

You will collaborate across teams to improve testing, inspection, and QC processes, perform failure analyses, and support internal audits. The role requires 2+ years in quality engineering (medical devices preferred), familiarity with QSR/ISO, and strong communication skills.

Qualifications

• Associate’s or Bachelor's degree in Engineering, a Life Science or a related field, with 2+ years of quality engineering or relevant experience, preferably in a medical devices environment, or equivalent combination of education and experience.
• Familiarity with QSR, ISO and other applicable regulations and laws required
• Engineering experience in a manufacturing environment recommended, medical device industry preferred
• Excellent verbal, written, and interpersonal communication skills
• Proficiency with MS Word, Excel, and PowerPoint

Responsibilities

• Collaborate in the development and qualification activities for new and existing products
• Collaborate in the development of testing and inspection methodology and documentation for new and existing products
• 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
• Analyze production limitations and standards
• Recommend revision of specifications
• Interface with other engineering departments within the company, customers, and suppliers on quality related issues
• Collaborate in the development of standard operating procedures
• Facilitate and perform internal audits
• Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures
• Understand relevant security, privacy and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company
• Ensure other members of the department follow the QMS, regulations, standards, and procedures
• Perform other work-related duties as assigned

Skills

Quality engineering experience

Regulatory knowledge (QSR/ISO)

Manufacturing environment experience

Communication skills

MS Word, PowerPoint, Excel

MS Word/Excel/PowerPoint proficiency

Education

Associate’s or Bachelor's degree in Engineering, Life Science or related field

Tools

MS Word

Excel

PowerPoint

Job description

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

You will collaborate across teams to improve testing, inspection, and QC processes, perform failure analyses, and support internal audits. The role requires 2+ years in quality engineering (medical devices preferred), familiarity with QSR/ISO, and strong communication skills.