Quality Engineer

Barry-Wehmiller • Boston, MA

22h

About The Position

As a Quality Engineer at Design Group, you will join the Regulatory Compliance Practice and work with industry experts, seasoned leaders, technical specialists, and subject matter experts to deliver consistent, accurate solutions for clients. You will support capital projects and implement solutions individually and as part of a team, helping clients improve performance and achieve their goals. The role focuses on ensuring processes adhere to quality standards throughout production, preparing procedures and testing methods, executing field test protocols, and identifying, interfacing with, and operating medical devices. The position may involve travel for project requirements, including installation and start-up activities, meetings, training, and industry events.

Requirements

• Co-op, internship, or project experience in life sciences, engineering, or consulting.
• 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 such as PFMEA/DFMEA.
• Experience with good documentation practices, cGMP, and FDA validation methods and systems.
• Ability to read engineering documents, set priorities, and work on multiple projects simultaneously.
• Strong verbal communication, technical writing, and word processing skills.
• Willingness to travel for project requirements, meetings, training, and industry events.
• Bachelor of Science in engineering, chemistry, microbiology, or a related technical degree, or equivalent experience as a project manager or quality engineer.

Nice To Haves

• Experience authoring and executing systems qualifications (IQ/OQ/PQ) for clean utilities, facilities, manufacturing, and packaging equipment.

Responsibilities

• Support capital projects and implement client solutions, both individually and as part of a team.
• Ensure 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 with, and operate medical devices.
• Travel as needed for installation and start-up activities, client and company meetings, training, and industry events.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level