Senior Quality Engineer – Medical Devices

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

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

401(k) with employer match

Paid parental leave

Holidays and vacation

Job summary

Penumbra, Inc. in Roseville, California, is seeking a Quality Engineer III to develop and implement quality system elements ensuring compliance with applicable regulations and standards for new and existing products.

The role addresses advanced scope problems, exercising sound judgment to determine actions and communicating quality objectives across the organization, including mentoring junior staff and collaborating with colleagues in multiple departments.

Qualifications

• Associate’s or bachelor’s degree in Engineering, Life Sciences, or a related field.
• Three or more years of quality engineering or related experience, preferably in a medical device environment.
• 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 engineering

QSR/ISO familiarity

Leadership

Communication skills

MS Office proficiency

Education

Bachelor's degree in Engineering or Life Sciences

Tools

Microsoft Word

Excel

PowerPoint

Job description

Penumbra, Inc. in Roseville, California, is seeking a Quality Engineer III to develop and implement quality system elements ensuring compliance with applicable regulations and standards for new and existing products.

The role addresses advanced scope problems, exercising sound judgment to determine actions and communicating quality objectives across the organization, including mentoring junior staff and collaborating with colleagues in multiple departments.