Supplier Quality Engineer
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merckin the United States and Canada, is a global health care leader with adiversified portfolio of prescription medicines, vaccines and animal healthproducts. The difference between potential and achievement lies in the sparkthat fuels innovation and inventiveness; this is the space where Merck hascodified its legacy for over a century. Merck’s success is backed byethical integrity, forward momentum, and an inspiring mission to achieve newmilestones in global healthcare.Responsible for serving as a primary point of contact for high risk and escalated suppliers for Merck / MSD Animal Health sites and occasional support for Merck / MSD Human Health sites. Will support the Primary Packaging category while assisting four other categories (i.e. Secondary Packaging, Glass, Product Contact Components and Raw Materials).
Responsible for implementing procedures and best practices supporting Merck's / MSD’s SD&PM organization, under the direction of the SD&PM Associate Director. The incumbent will exercise leadership in monitoring and maintaining supplier compliance with worldwide regulatory requirements, current Good Manufacturing Practices (cGMPs), MMD Human Health Quality Manual, Animal Health Quality Manual, Quality Management Systems (QMS), and pertinent legal and/or business contract requirements. Key responsibilities include leading supplier deviation investigations, upskilling suppliers for Quality, Compliance and Regulatory improvements, and interfacing with Merck / MSD sites. The incumbent will assist the SD&PM Associate Director in driving completion of Supplier Improvement Plans with suppliers and interfacing with Merck / MSD site Operations, Quality, Planning, Global Procurement and Global Technology Operations colleagues.
The incumbent will possess Analytical, Scientific, Technical, Manufacturing, and/or Quality experience in order to effectively administer and control Quality and Technical programs and projects needed to manage suppliers.
Primary Roles include, but are not limited to:
- Travels up to 50% of the time, to and from supplier sites and Merck / MSD sites within the region.
- Serves as a primary point of contact to Merck / MSD sites and suppliers in the region.
- Assigned to the Primary Packaging category, but will provide support to all of the categories, as needed.
- Responsible for coordination, oversight and communication on matters related to the regulatory or ISO status with the suppliers. Must understand worldwide regulatory requirements and current Good Manufacturing Practices.
- Acts as a liaison between suppliers and internal Merck / MSD site personnel.
- Travels to and from supplier locations to resolve Manufacturing, Quality, Technical and supply issues and investigations, as well as facilitates overall Quality improvements to proactively prevent supplier issues. Utilizes enhanced problem-solving skills to determine true root cause and development of irreversible corrective actions.
- Develops and executes Supplier Improvement Plans (SIPs).
- Coordinates, communicates and oversees general technical matters pertaining to suppliers, including understanding and optimizing component / material usage and upskilling suppliers to provide improved materials and services.
- Provides efficient and effective solutions and Corrective Actions / Preventative Actions (CAPAs) to suppliers and / or site issue resolution, including Deviation Management and customer complaints.
- Provides supplier investigation ownership using tools such as the Supplier Escalation Report (SER) and communicates results in weekly Tier meetings.
- Provides technical inputs, review, and execution of Quality Agreements.
- Tracks and monitors supplier operational and quality performance. Escalates issues to the SD&PM Performance Management Associate Director and site personnel.
- Assists in development and delivery of supplier metrics and scorecards.
- Participates in periodic business review meetings with suppliers.
- Works at a Merck / MSD site and provides SD&PM support to the Merck / MSD site.
Education Minimum Requirement:
BS/BA degree in Engineering, Science, or Business
Required Experience and Skills**:
Minimum of 5 years of experience in Business, Quality, Technical, or Manufacturing functions.
Knowledge of cGMPs, technical writing skills, data management, collection and analysis.
Demonstrated leadership, interpersonal, and communication skills.
Preferred Experience and Skills:
Networking, negotiations, and relationship building skills.
Merck Leadership Behaviors and Inclusive Behaviors.
Experience working with Animal Health suppliers and Merck / MSD sites.
Experience solving complex problems.
Green Belt and/or Black Belt sigma certifications are desired and an expectation if not accomplished at the time of hire into the position.
Excellent interpersonal, inclusion, and communication skills
Appreciation and respect for diversity, cultures, and norms
Works independently with all levels of the organization, and has demonstrated the following skills:
o Rapid / Disciplined decisions
o Acts with courage and candor
o Drives results
o Escalation of issues / concerns to management, as appropriate
o Ability to Prioritize, Align and Simplify
Your role at Merck is integral to helping the world meet newbreakthroughs that affect generations to come, and we’re counting on yourskills and inventiveness to help make meaningful contributions to globalmedical advancement. At Merck, we’re inventing for life.
Ifyou need assistance and/or a reasonable accommodation due to a disabilityduring the application or the recruiting process, please send a requestto email@example.com.
Search Firm Representatives Please Read Carefully:
Merck& Co., Inc. is not accepting unsolicited assistance from search firms forthis employment opportunity. Please, no phone calls or emails. Allresumes submitted by search firms to any employee at Merck via email, theInternet or in any form and/or method without a valid written search agreementin place for this position will be deemed the sole property of Merck. Nofee will be paid in the event the candidate is hired by Merck as a result of thereferral or through other means.
Visasponsorship is not available for this position.
Formore information about personal rights under Equal Employment Opportunity,visit:
Job: Supplier Dev & Perf Mgmt
Other Locations: DeSoto, KS, US; Elkhorn, NE, US
Employee Status: Regular
Travel: Yes, 50 % of the Time
Number of Openings: 1
Shift (if applicable):
Company Trade Name: Merck