Quality Engineer II - Complaints (hybrid)

About the Role

The Engineer II, Quality – Complaints is a product quality representative providing hands-on technical quality engineering support for product complaint investigations across multiple manufacturing facilities. This role guides Quality and Operations teams at manufacturing sites to ensure investigation findings are appropriately addressed. It involves direct interaction with customers and Global Field sales representatives, including customer conference calls and visits to understand product issues, identify concerns, and represent the Quality organization.

Responsibilities

• Serve as a product expert, understanding product design, manufacturing processes, failure modes, and field usage.
• Methodically process and investigate medical device customer complaints in a high-paced, efficient, and accurate manner.
• Write effective investigation reports and ensure timely completion.
• Provide quality support and cross-functional communication of customer experiences and complaint findings with manufacturing sites.
• Act as a liaison with Quality, Engineering, Operations, and manufacturing locations to understand ongoing CAPA investigations and product issues.
• Contact U.S. customers to address ongoing issues, proactively identify potential issues, and provide updates on quality initiatives impacting the customer.
• Analyze weekly and monthly trend data to identify biases or trends.
• Work effectively in a team environment with shifting priorities and time-sensitive requirements.
• Carry out basic standardized test methods and/or submit functional testing requests.
• Handle used and potentially contaminated medical devices in a controlled setting.
• Perform independent analysis and develop solutions to problems, including writing detailed design specifications.
• Receive general project direction and solicit input from more experienced engineers.
• Assist in training new and current employees on documentation, equipment use, laboratory techniques, and department procedures.
• Deliver tailored communications to managers, peers, and customers to maximize utility and promote cross-functional collaboration.
• Work on special projects as they arise.

Requirements

• Experience working in a team environment to bring medical device products through an FDA regulatory pathway and compliance with internal Quality Management System (QMS).
• Experience writing requirements and specifications for regulated products, including design traceability and verification/validation plans.
• Ability to train and transfer knowledge to others.
• Proficiency with measurement and test equipment.
• Creative problem-solving skills with the ability to troubleshoot a variety of issues.
• Proficient in Microsoft Office (Excel, Word, Database) and statistical analysis programs.
• Strong written and verbal communication skills.
• Strong knowledge of plastic processing and disposable medical device manufacturing.
• Good mechanical aptitude.
• Ability to safely and competently handle returned contaminated medical devices.
• Competency in your domain with familiarity in other areas of team expertise.
• Basic to intermediate understanding of engineering discipline and best practices.
• Awareness of broader product strategy and ability to contribute to it.
• Ability to receive general project direction and independently make decisions impacting project objectives.

Qualifications

• Must be at least 18 years of age.
• Bachelor’s degree from an accredited college or university in Engineering, Technology, or a STEM field.
• 2-4 years of experience.
• CQE/CRE Certification desirable.
• Prior experience in quality assurance preferred.
• Previous experience in a regulated manufacturing or pharmaceutical/healthcare environment preferred but not required.

Work Environment

This is largely a sedentary role operating in a professional office environment, routinely using standard office equipment. The position requires working with contaminated medical devices in a controlled laboratory setting. Must be able to occasionally move objects up to 15 lbs. Travel is typically less than 5% of the time.

About Us

ICU Medical is a global market leader in IV therapy and critical care products for hospital, alternate site, and home care settings. With a focus on consistent quality, innovation, and value, ICU Medical provides clinically-essential products, including IV sets, needlefree connectors, IV smart pumps, and IV medication safety software.