Quality Engineer III

Penumbra • Roseville, CA

6d • $98,000 - $137,000 • Onsite

About The Position

The Quality Engineer III will independently develop and implement appropriate quality system elements to ensure the high-quality level of new and existing products as well as their compliance with applicable regulations and standards. Work with problems of advanced scope where the analysis of situation or data requires a review of identifiable factors. Exercise judgment to determine appropriate action. Communicate and implement quality objectives.

Requirements

• Associate’s or Bachelor's degree in Engineering, a Life Science or a related field with 3+ years of quality engineering or relevant experience, preferably in a medical devices environment, or equivalent combination of education and experience
• Familiarity with QSR, ISO and other applicable regulations and laws required
• Excellent verbal, written, and interpersonal communication skills required
• Proficiency with MS Word, Excel and PowerPoint required

Nice To Haves

• Leadership skills desired

Responsibilities

• Collaborate and/or help lead in the development and qualification activities for new and existing products
• Collaborate and/or help lead in the development of testing and inspection methodology and documentation for new and existing products
• Collaborate and/or help lead 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 revision of specifications
• Interface with other engineering departments within the company, customers, and suppliers on quality related issues
• Collaborate and/or help lead in 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 domestic and global quality system regulations, standards, and procedures.
• Understand relevant security, privacy and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company.
• Ensure other members of the department follow the QMS, regulations, standards, and procedures.
• Perform other work-related duties as assigned.

Benefits

• A collaborative teamwork environment where learning is constant, and performance is rewarded.
• The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases.
• A generous benefits package for eligible employees that includes medical, dental, vision, life, AD&D, short and long-term disability insurance, 401(k) with employer match, an employee stock purchase plan, paid parental leave, eleven paid company holidays per year, a minimum of fifteen days of accrued vacation per year, which increases with tenure, and paid sick time in compliance with applicable law(s).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree
• Number of Employees: 5,001-10,000 employees