Quality Engineer - Life Sciences & Regulatory Compliance

Barry-Wehmiller Companies Inc.; Boxborough (MA); On-site; USD 85,000 - 125,000; Full time

Job summary

Barry-Wehmiller Design Group is seeking a Quality Engineer to join our expanding team of professionals. You will contribute to capital projects, work with clients, and help solve complex manufacturing and regulatory challenges.

You will collaborate with experts across engineering, life sciences, and compliance to deliver high-quality solutions. This role emphasizes procedures, documentation, and field testing in a dynamic environment.

Qualifications

• Co-op, internship, or project experience in life sciences, engineering, or consulting.
• Experience drafting SOPs 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

• You will 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

Skills

Co-op/internship

QSR systems

Change control

IQ/OQ/PQ

FDA validation

Read engineering docs

Verbal communication

Travel willingness

Education

B.S. in Engineering/ Chemistry/ Microbiology

Job description

Barry-Wehmiller Design Group is seeking a Quality Engineer to join our expanding team of professionals. You will contribute to capital projects, work with clients, and help solve complex manufacturing and regulatory challenges.

You will collaborate with experts across engineering, life sciences, and compliance to deliver high-quality solutions. This role emphasizes procedures, documentation, and field testing in a dynamic environment.