Quality Engineer II - Catheters

General Summary 

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. Work with problems of moderate 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. 

Specific Duties and 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 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 

*Indicates an essential function of the role 

Position Qualifications 

Minimum education and experience: 

• 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.  

Additional qualifications:   

• 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, such as a printer or copy machine, for an extensive period of time 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.