Quality Engineer

Who You’ll Work With

You will join one of our 45 offices in the US, be part of a committed team of over 1500 professionals, and work in teams and directly with our clients doing work that is shaping the world around us. You will be welcomed into a rapidly growing business and team and empowered to make an impact. You will be valued, cared for, and challenged on your path to becoming a world-class professional consultant and surrounded by leaders who are committed to creating an environment that enables you to realize your own success and fulfillment.

When you join Design Group as a Quality Engineer, you are joining a team that will challenge you and position you for growth. In this role, you will work with a team of industry experts to help the world’s leading companies solve their most difficult problems. You will join our Regulatory Compliance Practice and partner with seasoned leaders, technical specialists, and subject matter experts to deliver the highest quality solutions to our clients with consistency and accuracy.

What You’ll Do

You'll work individually and in teams to support capital projects and implement solutions for our clients. Together, you will help our clients make critical changes to improve their performance and realize their most important goals.

• Ensure that processes adhere to quality standards during all phases of production:
• Draft standard operating procedures, work instructions, and inspection, evaluation, and testing methods
• Execute field test protocols including IQ, OQ, PQ, and PV
• Identify, interface, and operate medical devices
• Make an impact day-to-day with your skills and expertise, strengthening that relationship with our clients and team
  
  
  

What You’ll Bring:

• A minimum of 3 years of experience in life sciences, medical devices, or other FDA regulated environments, preferably in ISO 13485 or ISO 9001
• Experience drafting standard operating procedures and methods for inspection, testing, and evaluation
• Experience working with QSR systems including calibration, maintenance, CAPA, and non-conformances
• Experience utilizing change control, risk management, and mitigation tools (PFMEA/DFMEA)
• Experience authoring and executing systems qualifications (IQ/OQ/PQ) for clean utilities, facilities, manufacturing, and packaging equipment (preferred)
• Experience with good documentation practices, cGMP, and FDA validation methods and systems
• The ability to read engineering documents, set priorities, and work on multiple projects simultaneously
• Strong verbal communication, technical writing, and word processing skills
• A willingness to travel for project requirements including installation and start-up activities, client and company sponsored meetings, trainings, industry related seminars, forums, and conventions
• A bachelor of science in engineering, chemistry, microbiology, or a related technical degree, or equivalent experience as a project manager or quality engineer
  
  
  

Our culture and commitment to our people is what sets us apart. We foster an environment of mutual respect, integrity, and unconditional interest in the individual and collective success of our professionals. Our model and entrepreneurial mindset offer a rewarding, challenging, and highly flexible path. As a Quality Engineer, you will build a meaningful and fulfilling career with the support of professional development resources and mentorships including our First Year Experience program, Individual Development Plans, and Career Path resources and tools. You will be surrounded by exceptional talent who will support your development as both a world-class engineer and a highly effective leader.

Feel like you're on the path to becoming a Quality Engineer, but you're not quite there yet? We'd love to connect with you to see if we can take you from where you are today and grow you into a Design Group Engineering Consultant.