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BW Design Group · 11 hours ago

Quality Engineer

Boston, MA

Full-time

Hybrid

Mid Level

3+ years exp

BW Design Group is a rapidly growing company with over 1500 professionals across 45 offices in the US. As a Quality Engineer, you will be part of a committed team that supports capital projects and implements solutions for clients, ensuring adherence to quality standards throughout production phases.

Industrial Automation

Responsibilities

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

Plans and directs activities concerned with development, application, and maintenance of quality standards for industrial processes, materials and products

Engages in quality control processes or procedures including product inspection, testing and analysis of products, reporting on quality to management, and approving or denying product release

Establishes programs to evaluate precision and accuracy of equipment

Other duties as assigned

Qualification

ISO 13485ISO 9001QSR systemsCGMPRisk managementChange controlTechnical writingWord processingVerbal communicationProject management

Required

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 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