Senior Medical Device Quality Engineer

Penumbra, Inc.; Roseville (CA); On-site; USD 98,000 - 137,000; Full time

Benefits offered by this job

Generous benefits package

Equity program

Job summary

Penumbra, Inc. in Alameda, California, is seeking a Quality Engineer III to independently develop and implement quality system elements ensuring high product quality and regulatory compliance.

The role requires collaboration across departments to lead development, testing methodologies, and internal audits, while mentoring junior engineers and adhering to QMS and applicable standards. The position offers a competitive salary and benefits.

Qualifications

• Associate’s or bachelor’s degree in Engineering, Life Sciences, or related field.
• Three+ years of quality engineering experience, preferably in a medical device environment.
• An equivalent combination of education and experience may be considered.
• Familiarity with Quality System Regulations (QSR), ISO standards, and other applicable regulations and laws.

Responsibilities

• Collaborate on and/or help lead development and qualification activities for new and existing products.
• Collaborate on and/or help lead the development of testing and inspection methodologies and documentation for new and existing products.
• Collaborate on and/or help lead Quality Objective teams.
• Design and implement quality control 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 revisions to specifications.
• Partner with other engineering departments, customers, and suppliers to address quality-related issues.
• Collaborate on and/or help lead the development of standard operating procedures.
• Facilitate and perform internal audits.
• Perform responsibilities required by the Quality System and other duties as assigned or requested.
• Provide guidance to junior Quality Engineers and interns in support of departmental functions.
• Adhere to the Company's Quality Management System (QMS), as well as applicable domestic and global quality system regulations, standards, and procedures.
• Understand relevant security, privacy, and compliance principles and adhere to applicable Company regulations, standards, and procedures.
• Ensure that other department members follow the QMS and applicable regulations, standards, and procedures.
• Perform other work-related duties as assigned.
• Indicates an essential function of the role.

Skills

Quality engineering

Verbal communication

Written communication

Leadership

Interpersonal skills

Education

Bachelor’s / Associate degree in Engineering or Life Sciences

Tools

MS Word

MS Excel

MS PowerPoint

Job description

Penumbra, Inc. in Alameda, California, is seeking a Quality Engineer III to independently develop and implement quality system elements ensuring high product quality and regulatory compliance.

The role requires collaboration across departments to lead development, testing methodologies, and internal audits, while mentoring junior engineers and adhering to QMS and applicable standards. The position offers a competitive salary and benefits.