Quality Engineer II - Catheters
About the Role
The Quality Engineer II develops and implements 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. This role involves working with problems of moderate scope where analysis of situations or data requires a review of identifiable factors and exercising judgment to determine appropriate action. The position also includes communicating and implementing quality objectives.
Responsibilities
- Collaborate in the development and qualification activities for new and existing products
- Collaborate in the development of testing and inspection methodology 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 revision of specifications
- Interface with other engineering departments within the company, customers, and suppliers on quality-related issues
- Collaborate in the development of standard operating procedures
- Facilitate and perform internal audits
- 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 applicable regulations, standards, and procedures
- Ensure other members of the department follow the QMS, regulations, standards, and procedures
- Perform other work-related duties as assigned
Qualifications
- Associate’s or Bachelor's degree in Engineering, a Life Science, or a related field, with 2+ 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
- Engineering experience in a manufacturing environment recommended; medical device industry preferred
- Excellent verbal, written, and interpersonal communication skills
- Proficiency with MS Word, Excel, and PowerPoint
Working Conditions
- General office, laboratory, and cleanroom environments
- Potential exposure to blood-borne pathogens
- Requires some lifting and moving of up to 25 pounds
- Must be able to move between buildings and floors
- Must be able to remain stationary and use a computer or other standard office equipment for extensive periods each day
- Must be able to read, prepare emails, and produce documents and spreadsheets
- Must be able to move within the office and access file cabinets or supplies, as needed
- Must be able to communicate and exchange accurate information with employees at all levels on a daily basis
Pay
Annual Base Salary Range: $85,000 to $114,000
Benefits
- Medical, dental, vision, life, and AD&D insurance
- Short and long-term disability insurance
- 401(k) with employer match
- Paid parental leave
- Eleven paid company holidays per year
- A minimum of fifteen days of accrued vacation per year, increasing with tenure
- Paid sick time in compliance with applicable law(s)
About the Company
Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures, and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. Penumbra sells its products to hospitals and healthcare providers primarily through its direct sales organization in the United States, most of Europe, Canada, and Australia, and through distributors in select international markets.