Quality Engineer Jobs

About The Position

Requirements

• Bachelor’s or master’s degree in Mechanical, Industrial, Electrical Engineering, or a related field preferred.
• At least 2 years of related experience.
• Experience in FDA- or ISO-regulated manufacturing environments, including GMP compliance, inspection readiness, ISO 13485, CAPA, nonconformance management, change control, document control, and risk management.
• Knowledge of validation and manufacturing processes, including equipment, process, product, and software validation (IQ/OQ/PQ), risk-based validation, and manufacturing controls.
• Proficiency with problem-solving, risk assessment, and data analysis tools, including FMEA, 5 Whys, Fishbone, SPC, DOE, capability analysis, trending, and process monitoring.
• Experience with quality and business systems such as Minitab, JMP, Excel, Power BI, and SAP.
• Strong communication, collaboration, continuous improvement, and critical-thinking skills.
• Availability for first shift.

Nice To Haves

• Lean Six Sigma certification.
• Automation or programming experience.

Responsibilities

• Develop, modify, apply, and maintain quality standards and protocols for processing materials into partially finished or finished products.
• Collaborate with engineering and manufacturing functions to ensure quality standards are in place.
• Devise and implement methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment.
• Design or specify inspection and testing mechanisms and equipment; conduct quality assurance tests; and perform statistical analysis to assess the cost of and determine responsibility for products or materials that do not meet required standards and specifications.
• Ensure corrective measures meet acceptable reliability standards and documentation complies with requirements.
• Work in quality-related areas such as design, incoming materials, production control, product evaluation and reliability, inventory control, or research and development, as applicable.
• Collaborate with cross-functional teams to develop solutions and improve manufacturing processes.