Quality Assurance Manager

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

The Quality Manager is a hands-on role that requires aptitude, energy to build a QMS from the ground up. We are in the midst of a significant culture change. The successful candidate needs to drive for results. This operation does not fall under regulatory guidelines, therefore, a regulatory understanding or background is not needed. However, the Quality Manager will be the champion for quality by design and continuous improvement that ensures every product is processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality. The Quality Manager partners across our internal manufacturing facilities, external contract manufacturers and suppliers to create an interdependent global manufacturing network committed to deliver a compliant, on time, and reliable supply to customers. This position receives direction from the Associate Director of Operations, interfaces directly across all functional areas and interacts daily with senior leadership.

SPECIFIC RESPONSIBILITIES:

• Support implementation of all Quality processes Coordinate Quality activities for the assigned manufacturing unit.
• Analyze quality data to make recommendations for improvement focus areas.
• Develop and implement improvements via Kaizens.
• Work closely with Engineering to influence technical design decisions, meet custom product requirements, and reach business objectives.
• Implement containment, corrective actions and follow-up on quality issues – including facilitation of responses to findings and handling of Quality case documentation.
• Lead effective problem solving activities to investigate nonconformities.
• Serve as Quality liaison with support groups and cross functional teams.
• Coordination of Quality training
• Primary liaison for supplier quality activities
• Writes, reviews, and approves Standard Operating Procedures, Controlled Job Aides, Control Procedures, Quality Standards, etc.
• Promotes company strategic, departmental operational excellence and manufacturing regulatory initiatives.
• Accountable for acting as the quality representative on capital projects.
• Provides engineering and technical support for current products and new product launches.
• Interfaces with customer quality representatives concerning quality problems and assures that effective corrective action is implemented.
• Interprets customer specifications and requirements.
• Maintains good internal and external supplier quality levels.
• Designs and implements methods for process improvement, testing and inspection.
• Develops and analyses quality metrics and initiating change as needed.

GENERAL REQUIREMENTS:

• Ability to work with all levels of business customers in a highly dynamic environment.
• Comfortable with working closely across various teams including functional and procurement leadership teams.
• Willingness and ability to work flexible working hours.

Qualifications:

• BS Degree in Mechanical or Industrial Engineering preferred, or equivalent work experience may be considered.
• Minimum of five years of quality engineering experience in a manufacturing environment preferred.

Required Experience & Skills

• 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, such as Pareto charts/8D problem solving, FMEA, GR&R, FAI, CPK, PPAP etc.
• Ability to lead and facilitate training and continuous improvement initiatives.

Required Skills:

Analytical Problem Solving, Analytical Problem Solving, Analytical Thinking, Capital Projects, Case Documentation, cGMP Compliance, Decision Making, Detail-Oriented, Driving Continuous Improvement, Enterprise Resource Planning (ERP), Key Performance Indicators (KPI), Operational Excellence, Oral Communications, People Leadership, Process Improvements, Quality Auditing, Quality Control Systems, Quality Documentation, Quality Management Standards, Quality Management Systems (QMS), Root Cause Analysis (RCA), SAP Business Technology Platform (SAP BTP), SAP Enterprise Resource Planning (ERP), SAP Project System (PS), SAP Systems {+ 1 more}