Quality Engineer II - Catheters

Penumbra • Roseville, CA

1d • Onsite

About The Position

The Quality Engineer II develops and implements quality system elements to ensure the quality of new and existing products and their 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 actions, and communicates and implements quality objectives.

The position works with product development and qualification, testing and inspection methods, quality-control processes, failure analysis, investigations, audits, and standard operating procedures. It collaborates with engineering departments, customers, suppliers, and Quality Objective teams, and helps ensure compliance with the Company’s Quality Management System and applicable domestic and global regulations, standards, and procedures.

The role is based in Roseville, California, and works in general office, laboratory, and cleanroom environments. It may involve exposure to blood-borne pathogens and requires some lifting and moving of up to 25 pounds, as well as moving between buildings and floors. The position also requires extended periods of stationary computer and office-equipment use, reading and preparing documents and spreadsheets, moving within the office, and communicating with employees at all levels.

Requirements

• Associate’s or bachelor’s degree in Engineering, a Life Science, or a related field, or an equivalent combination of education and experience.
• At least 2 years of quality engineering or relevant experience.
• Familiarity with QSR, ISO, and other applicable regulations and laws.
• Excellent verbal, written, and interpersonal communication skills.
• Proficiency with MS 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.
• Experience in the medical-device industry 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 QC 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 internal 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 Quality Management System (QMS) and applicable domestic and global quality system regulations, standards, and procedures.
• Understand and follow applicable security, privacy, and compliance principles, 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 equity program, when applicable.
• Medical insurance.
• Dental insurance.
• Vision insurance.
• Life insurance.
• 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 laws.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree