Senior Quality Engineer

Barry-Wehmiller • Boston, MA

1d

About The Position

BW Design Group is a fully integrated architecture, engineering, construction, system integration, and consulting firm serving clients in food and beverage, life sciences, industrial, and advanced technology. The Senior Quality Engineer joins the Regulatory Compliance Practice and works with industry experts, technical specialists, and subject matter experts to deliver quality solutions to clients. The position supports capital projects and helps clients implement changes that improve performance and achieve important goals.

The engineer ensures processes adhere to quality standards throughout production, prepares procedures and inspection methods, executes field test protocols, and works with medical devices. The role requires client collaboration and may involve travel for project work, installation and start-up activities, meetings, training, and industry events. The company describes a flexible career path supported by professional development resources, mentorship, Individual Development Plans, and career tools.

Requirements

• At least 10 years of experience in life sciences, medical devices, or another FDA-regulated environment; experience in ISO 13485 or ISO 9001 is preferred.
• Experience drafting standard operating procedures and methods for inspection, testing, and evaluation.
• Experience with quality system elements including calibration, maintenance, CAPA, and non-conformances.
• Experience using change control, risk management, and mitigation tools such as PFMEA and 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, client and company meetings, training, and industry events.
• Bachelor of Science in engineering, chemistry, microbiology, or a related technical field, 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.
• Experience in ISO 13485 or ISO 9001 environments.

Responsibilities

• Support capital projects and implement solutions for clients, working 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.
• Work with clients and team members to help improve performance and achieve client goals.
• Travel as required for project work, including installation and start-up activities, meetings, training, and industry events.

Benefits

• Professional development resources and mentorship, including the First Year Experience program, Individual Development Plans, and Career Path resources and tools.
• Flexible career path.

What This Job Offers

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