Quality Engineer - Medical Device, Process Validation Risk

Exemplar Global; Grand Rapids (MI); Presencial; USD 75.000 - 110.000; Jornada completa

Descripción de la vacante

Insight Global is seeking a Quality Engineer for a client in the medical device/manufacturing sector in Grand Rapids, MI. You will support new product development, perform process validation, manage risk, and drive continuous quality improvements across the product lifecycle.

Candidate should have 3+ years of quality engineering experience in regulated environments, with knowledge of FDA/ISO/GMP, CAPA, RCA, and statistical analysis tools such as Minitab.

Formación

• 3+ years of quality engineering in a regulated manufacturing environment.
• Experience with process validation, risk management, CAPA, root cause analysis, and quality investigations.
• Knowledge of FDA, ISO, GMP, and related quality standards.
• Experience with statistical analysis tools.
• Familiarity with Lean Manufacturing, 5S, and Six Sigma.
• Strong project management, communication, and cross-functional collaboration skills.
• Proficiency with Microsoft Office and quality/statistical software such as Minitab.
• Ability to manage multiple priorities in a fast-paced environment.

Responsabilidades

• Support new product development activities, including risk assessments, design controls, and specification reviews.
• Develop and maintain risk management documentation, including DFMEA and PFMEA analyses.
• Create and execute process validation protocols, reports, and associated quality documentation.
• Lead root cause investigations using tools such as 5 Whys, Fishbone Diagrams, and corrective action methodologies.
• Investigate nonconforming materials, customer complaints, and quality events to identify and implement corrective actions.
• Support change control processes and ensure compliance with quality management system requirements.
• Utilize statistical methods and quality engineering tools to analyze process and product performance.
• Partner with Engineering, Operations, R&D, and Manufacturing teams to drive quality improvements.
• Support internal and external audits, inspections, and regulatory compliance activities.
• Perform additional duties as assigned.

Conocimientos

Quality engineering

Regulatory knowledge

CAPA

Root cause analysis

Quality investigations

Cross-functional collaboration

Project management

Lean Six Sigma

Herramientas

Minitab

Microsoft Office

Descripción del empleo

Insight Global is seeking a Quality Engineer for a client in the medical device/manufacturing sector in Grand Rapids, MI. You will support new product development, perform process validation, manage risk, and drive continuous quality improvements across the product lifecycle.

Candidate should have 3+ years of quality engineering experience in regulated environments, with knowledge of FDA/ISO/GMP, CAPA, RCA, and statistical analysis tools such as Minitab.