Merck & Co.→
Quality Assurance Manager at Merck & Co. in Irving, TX
Skills
Job Description
Job Description
For over 130 years, we have pioneered groundbreaking science. Today, we are driven by continuous innovation to develop breakthrough medicines, vaccines and technology. Rooted in direct experience on the farm and in the clinic, we work hand in hand with our customers every step of the way.
Our singular focus is to empower those who care for animals, helping them manage their vital responsibility with confidence. Because when it comes to animal health, no one sees it like we do.
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:
Key Competencies:
- 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:
Education Minimum Requirements
- 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}
Preferred Skills:
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Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts
The primary location for this posting is: USA - Texas - Irving
Where required by law, the compensation range for this role is provided below.
The salary range for the primary location of this role is: $96,200.00 - $151,400.00
This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.
Additional location(s): Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.
Additional location(s) Compensation Information:
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance
Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status: Regular
Relocation: No relocation
VISA Sponsorship: No
Travel Requirements: 10%
Flexible Work Arrangements: Not Applicable
Shift: 1st - Day
Valid Driving License: No
Hazardous Material(s): N/A
Job Posting End Date: 11/18/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.