Quality Engineer

Barry Wehmiller Company • Boston, MA

245d

About The Position

BW Design Group is a fully integrated architecture, engineering, construction, system integration, and consulting firm committed to helping our clients realize their most critical goals from Strategy to Commercialization. As the only firm born from a manufacturing technology company to become an independent and fully integrated firm, we combine deep domain expertise in the manufacturing environment with an approach that is built to serve the dynamic needs of our clients. Rooted in our distinct culture of Truly Human Leadership, we cultivate the leaders who will define tomorrow and partner with our clients in the food & beverage, life sciences, industrial, and advanced technology industries to build the future of manufacturing and technology. Barry-Wehmiller is a diversified global supplier of engineering consulting and manufacturing technology for the packaging, corrugating, sheeting and paper-converting industries. By blending people-centric leadership with disciplined operational strategies and purpose-driven growth, Barry-Wehmiller has become a $3 billion organization with nearly 12,000 team members united by a common belief: to use the power of business to build a better world.

Requirements

• 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.

Responsibilities

• Support capital projects and implement solutions for clients.
• 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.
• Strengthen relationships with clients and team through expertise.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Machinery Manufacturing
• Education Level: Bachelor's degree