Senior Quality Engineer - Medical Devices

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

Benefits offered by this job

Medical, dental, vision insurance

Life and AD&D insurance

401(k) with employer match

Paid parental leave

Eleven paid company holidays per year

Paid vacation and sick time

Job summary

Penumbra, Inc. in Roseville, California, seeks a Quality Engineer III to independently develop and implement quality system elements for medical devices, ensuring compliance with applicable standards and regulations.

This role involves leading QA activities across the organization, mentoring junior engineers, and collaborating with design, manufacturing, and suppliers to drive continual quality improvements in a regulated environment. A strong benefits package is provided.

Qualifications

• Three or more years of quality engineering or related experience, preferably in a medical device environment.
• Associate’s or bachelor’s degree in Engineering, Life Sciences, or a related field.
• An equivalent combination of education and experience may be considered.

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.

Skills

Quality system knowledge

Regulatory awareness

Leadership potential

MS Office proficiency

Education

Bachelor’s degree in Engineering, Life Sciences, or related field

Associate’s degree in Engineering, Life Sciences, or related field

Tools

MS Word

MS Excel

MS PowerPoint

Job description

Penumbra, Inc. in Roseville, California, seeks a Quality Engineer III to independently develop and implement quality system elements for medical devices, ensuring compliance with applicable standards and regulations.

This role involves leading QA activities across the organization, mentoring junior engineers, and collaborating with design, manufacturing, and suppliers to drive continual quality improvements in a regulated environment. A strong benefits package is provided.