Quality Engineer III - Catheters

General Summary

The Quality Engineer III will independently develop and implement appropriate quality system elements to maintain a high level of quality for new and existing products and ensure compliance with applicable regulations and standards.

This role addresses problems of advanced scope where the analysis of situations or data requires a review of identifiable factors. The Quality Engineer III will exercise sound judgment to determine appropriate actions and will communicate and implement quality objectives across the organization.

Specific Duties and 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.

Position Qualifications

Minimum Education and Experience

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.

Additional Qualifications

Familiarity with Quality System Regulations (QSR), ISO standards, and other applicable regulations and laws.

Excellent verbal, written, and interpersonal communication skills.

Demonstrated or developing leadership skills preferred.

Proficiency with Microsoft Word, Excel, and PowerPoint.

Location : Roseville, California

Annual Base Salary Range: $98,000 to $137,000

We offer a competitive compensation package, along with benefits and an equity program when applicable.

Individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location.

Working Conditions

Work is performed in general office, laboratory, and cleanroom environments.

Business travel may range from 0% to 10%.

May occasionally be required to lift and move items weighing up to 25 pounds.

Must be able to move between buildings and floors.

Must be able to remain stationary and use a computer and other standard office equipment, such as printers and copy machines, for extended periods each day.

Must be able to read and prepare emails, documents, and spreadsheets.

Must be able to move throughout the office and access file cabinets and supplies as needed.

Must be able to communicate and exchange accurate information with employees at all organizational levels on a daily basis.