Quality Engineer 1, EU MDR

Minimum Qualifications

• Bachelor degree in STEM (Science, Technology, Engineering, Math),

• Develops physical and functional test requirements to assure specifications and regulations are met.
• Writes, reviews, and approves protocols, reports, and data.
• Conducts testing outlined in protocols and test methods.
• Executes validation studies on equipment and processes, and conducts and/or participates in complaints investigations.
• Understands and follows company procedures and regulatory requirements.
• Participates in and provides input to training on department & division procedures, and policies.
• Analyzes design, process, and test data.
• Prepares and presents oral and written project updates and technical discussions.
• Develops and implements procedures to provide easy to follow instructions.
• Develop sampling plans by applying attribute, variable, and sequential sampling methods. Develop local procedures, Test Methods, and standards.
• Develop and implement Statistical Process Control.
• Leads investigations related to quality problems.
• Ability to define and manage risk-management plan, risk assessment and risk-control tools.
• Facilitate or independently lead non-conforming product investigations, including corrective/preventive actions and product remedial actions.
• Responsible for systems assurance including documentation, testing and inspection, and product and process development.
• Will support Manufacturing, New Product Development, and Regulatory (as applicable) to ensure systems are in compliance with internal and external guidelines and regulations.
• Identify and lead product and systems continuous improvement initiatives.
• Communicate effectively at all levels within Quality, as well as cross-functionally with R&D, Regulatory Affairs, Manufacturing, Supply Chain, Customer Service, Marketing, and other functions as necessary.
• Execute design controls and analyzes design inputs.
• Will participate in internal/external audits.