Quality Engineer II - Catheters

Penumbra•Roseville, CA

3d•$85,000 - $114,000•Onsite

About The Position

The Quality Engineer II develops and implements quality system elements to support the quality of new and existing products and ensure compliance with applicable regulations and standards. The role addresses problems of moderate scope, reviews identifiable factors when analyzing situations or data, exercises judgment to determine appropriate action, and communicates and implements quality objectives. The position collaborates on product development and qualification, testing and inspection methods, quality objectives, and standard operating procedures. It also designs or specifies quality-control sampling systems and inspection or testing equipment, conducts failure analyses and defect investigations, analyzes production limitations and standards, recommends specification revisions, and facilitates and performs internal audits. The Quality Engineer II works with other engineering departments, customers, and suppliers on quality-related issues and helps ensure department members follow the company’s Quality Management System (QMS) and applicable domestic and global regulations, standards, and procedures. The role also requires adherence to relevant security, privacy, and compliance requirements and includes other work-related duties as assigned. The position is located in Roseville, California. Work takes place in general office, laboratory, and cleanroom environments, with potential exposure to blood-borne pathogens. The role requires occasional lifting and moving of items weighing up to 25 pounds, movement between buildings and floors, and regular use of a computer and other standard office equipment.

Requirements

Associate’s or bachelor’s degree in Engineering, a Life Science, or a related field, with at least 2 years of quality engineering or relevant experience; an equivalent combination of education and experience is also accepted.
Familiarity with QSR, ISO, and other applicable regulations and laws.
Excellent verbal, written, and interpersonal communication skills.
Proficiency with Microsoft Word, Excel, and PowerPoint.

Nice To Haves

Quality engineering or relevant experience in a medical-device environment is preferred.
Engineering experience in a manufacturing environment is recommended.
Medical device industry experience is preferred.

Responsibilities

Collaborate in development and qualification activities for new and existing products.
Collaborate in developing testing and inspection methodologies and documentation for new and existing products.
Collaborate on Quality Objective teams.
Design and install 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.
Interface with engineering departments, customers, and suppliers on quality-related issues.
Collaborate in developing standard operating procedures.
Facilitate and perform internal audits.
Adhere to the company’s QMS and applicable domestic and global quality-system regulations, standards, and procedures.
Follow relevant security, privacy, and compliance principles and applicable regulations, standards, and procedures.
Ensure other department members follow the QMS, regulations, standards, and procedures.
Perform other work-related duties as assigned.

Benefits

Competitive compensation package and benefits and equity program, when applicable.
Medical insurance.
Dental insurance.
Vision insurance.
Life insurance.
Accidental death and dismemberment (AD&D) insurance.
Short- and long-term disability insurance.
401(k) with employer match.
Paid parental leave.
Eleven paid company holidays per year.
At least fifteen days of accrued vacation per year, increasing with tenure.
Paid sick time in compliance with applicable law.