Quality Engineer

• Investigate manufacturing product quality and compliance issues including complaints and process deviations.
• Manage NCRs, CAPAs, ECRs, and audit observations for production processes prior to final product release.
• Provide technical support for internal and external audits and prepare reports with recommendations.
• Oversee product release activities, including material review and disposition of on-hold products.
• Review and approve equipment validations and asset management actions.
• Optimize manufacturing processes using engineering methods such as Lean and Six Sigma.
• Identify opportunities for process improvements, redesign of equipment, tools, and fixtures to reduce risk.
• Collaborate with engineering teams to support product transfers and process improvements.
• Maintain and update risk management files and support failure mode analysis activities.
• Develop training materials and work instructions to support production processes.
• Support process validation activities and quality engineering responsibilities.
• Assign tasks, guide technicians, and provide training and feedback.
• Work independently while contributing to team-based projects and organizational goals.

Requirement/Must Have:

• Bachelor s degree in Engineering or a related scientific field.
• 2 4 years of relevant experience in quality or manufacturing engineering.
• Strong knowledge of quality systems, compliance, and manufacturing processes.
• Experience with NCR, CAPA, and audit processes.
• Understanding of process validation and quality control practices.
• Strong problem-solving, analytical, and organizational skills.
• Ability to work independently and in a team environment.

Experience:

• Experience working with lab or industrial equipment.
• Experience in manufacturing process improvement and validation.
• Exposure to statistical techniques and quality methodologies.

Responsibilities:

• Ensure product quality and compliance across manufacturing processes.
• Lead investigations and implement corrective actions.
• Support audits and validation activities.
• Collaborate with cross-functional teams to improve processes.
• Train and support technical staff.

Should Have:

• Knowledge of Lean and Six Sigma methodologies.
• Experience with risk management and failure analysis.
• Certified Quality Engineer certification preferred.
• Strong documentation and communication skills.

Skills:

• Strong analytical and critical thinking abilities.
• Effective communication and interpersonal skills.
• Organizational and time management skills.
• Ability to manage multiple priorities and stakeholders.
• Attention to detail and accuracy.

Qualification And Education:

• Bachelor s degree in Engineering required.
• Master s degree in Engineering or related field preferred.