Quality Engineer I – Electronics

Quality Engineer I – Electronics

Requirements

• Associate’s or Bachelor’s degree in Engineering, a Life Science or a related field, plus 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
• Experience with Electronic devices and/or PCBAs
• Excellent verbal, written, and interpersonal communication skills
• Proficiency with MS Word, Excel, and PowerPoint

Responsibilities

• Participate in the development and qualification activities for new and existing products
• Develop testing and inspection methodology and documentation for new and existing products
• Participate 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
• Work in compliance of standard operating procedures
• 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

Preferred Qualifications

• Engineering experience in a manufacturing environment recommended, medical device industry preferred
• Experience with Electronic devices and/or PCBAs