Quality by Design Leader: Build QMS & Continuous Improvement

Merck; Irving (TX); On-site; USD 105,000 - 160,000; Full time

Job summary

Merck seeks a hands-on Quality Manager to build a QMS from the ground up and drive a culture of continuous improvement across our manufacturing network. You will champion quality by design, coordinate with internal facilities and external partners, and report to the Associate Director of Operations.

You will lead quality processes, implement corrective actions, and manage training, while ensuring compliance with top-tier quality standards and customer requirements.

Qualifications

• BS Degree in Mechanical or Industrial Engineering preferred.
• Minimum of five years of quality engineering experience in a manufacturing environment preferred.
• Effective written and verbal communication skills.
• Strong supervisory and leadership skills; experience leading a team.
• Experience with SAP ERP system.
• Time Management: ability to manage changing workload, and complete tasks independently.
• Demonstrated analytical, Problem Solving/Decision Making: logical approach and acting despite obstacles or ambiguity.
• Ability to understand technical specifications and requirements.
• High Proficiency in Excel, Word, PowerPoint; familiarity with Power BI and Access a plus.
• Solid understanding on quality tools such as statistical process control, Pareto charts/8D problem solving, FMEA, GR&R, FAI, CPK, PPAP etc.
• Ability to lead and facilitate training and continuous improvement initiatives.

Responsibilities

• Support implementation of all quality processes and coordinate activities for the assigned manufacturing unit.
• Analyze quality data to recommend improvements.
• Develop and implement improvements via Kaizens.
• Work with Engineering to influence design decisions and meet product requirements.
• Implement containment, corrective actions, and follow-up on quality issues.
• Lead problem solving for nonconformities.
• Serve as Quality liaison with support groups and cross-functional teams.
• Coordinate Quality training.
• Act as primary liaison for supplier quality activities.
• Write, review, and approve SOPs and Quality documents.
• Promote operational excellence and regulatory initiatives.
• Act as quality representative on capital projects.
• Provide engineering support for current and new products.
• Interface with customer quality representatives to ensure effective corrective action.
• Interpret customer specifications and requirements.
• Maintain supplier quality levels.
• Design and implement methods for process improvement, testing and inspection.
• Develop and analyze quality metrics and initiate changes as needed.

Skills

Analytical Problem Solving

Decision Making

Detail-Oriented

People Leadership

SAP ERP

Time Management

Power BI

Excel

Word

PowerPoint

RCA

FMEA

GR&R

8D

PPAP

CPK

Education

BS Degree in Mechanical or Industrial Engineering

Tools

SAP ERP

SAP BTP

SAP PS

SAP Systems

Job description

Merck seeks a hands-on Quality Manager to build a QMS from the ground up and drive a culture of continuous improvement across our manufacturing network. You will champion quality by design, coordinate with internal facilities and external partners, and report to the Associate Director of Operations.

You will lead quality processes, implement corrective actions, and manage training, while ensuring compliance with top-tier quality standards and customer requirements.