Supplier Quality Engineer
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
The Supplier Development & Performance Management (SD&PM) Engineer in Supplier Development, will work closely with the SD&PM Team (Systems, Field Specialists, etc.) and a be a key technical interface with Merck Direct Material Suppliers (hereafter MMD Suppliers) and MMD Human Health / Animal Health sites on pro-active activities.
This interaction with MMD (Merck Manufacturing Division) Suppliers includes, but is not limited to, performing HyperCare activities at the Supplier manufacturing site to ensure a flawless launch, executing Supplier Technical Capability Assessments (TCA), Up-Skilling Suppliers, execution of Advanced Product Quality Planning (APQP) for new items, and leading Specification Alignment activities. In addition, the SD&PM Supplier Development Engineer will interface with Merck Global Sciences, Technology, and Commercialization (GSTC) group, and the Large and Small Molecule Lines of Business.
Primary Roles include, but are not limited to:1. Travels ~ 25% % of the time, to and from supplier sites and Merck / MSD sites within the region.2. Leading the execution of the Technical Capability Assessment (TCA) for new and existing Suppliers, to determine if gaps exist in 12 critical Supplier categories (e.g. Mold Asset Management, Material Flow, Sub Supplier Management, Change Control, Visual Management, 5 Why’s, etc.) and then Up-Skilling the Supplier to close those gaps.3. Performing HyperCare Activities (e.g. walk the lines at the Supplier Manufacturing Site and confirm in-process controls are in place, ensure that current Merck specifications / drawings are being used at Supplier, verify the release equipment in Supplier lab is the same as Supplier qualification and equivalent to Merck Lab, analyze Supplier release test results for Normality, X-Bar Chart, Histogram, Control Limits, etc.) prior to and/or during Supplier launch for MMD Supply.4. Partnering with Global Procurement to identify “high-risk” Items / Suppliers and then mitigating that risk (e.g. HyperCare, Technical Capability Assessment, etc.) for MMD sites.5. Performing a Gap Analysis between specifications, methods, equipment, etc. at MMD Suppliers vs. MMD plants and then mitigate those gaps (e.g. Gage R&R, etc.) to pro-actively reduce future deviations, supply issues, etc. due to misalignment between Merck and Supplier.6. Execution of Advanced Product Quality Planning (APQP), PPAP, SPC implementation, and Run-Out Rates.
Education Minimum Requirement:
BS/BA degree in Engineering, Science or equivalent scientific field
Required Experience and Skills**:
· Minimum of 5 years of experience in Quality, Technical, or Operations working with products or processes
· Demonstrated Quality, Technical and/or Manufacturing experience in the areas of chemical, pharmaceutical, animal health and/or vaccine manufacturing, packaging, or supplier management
· Demonstrated problem-solving skills
· Proven self-starter
Preferred Experience and Skills:
· Work experience and knowledge of the Animal Health business, if supporting the Animal Health division
· Ability to develop and/or improve commercial relationships
· Ability to work within a matrix organization and leverage expertise from other Merck functions and departments
· Knowledge of global compliance requirements for Human Health and Animal Health, technical writing, data management, collection, and analysis
· Merck Sigma Black Belt and/or Green Belt certification is preferred
· Possesses excellent interpersonal, inclusion, and communication skills
· Appreciates and respects 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 and/or concerns to management, as appropriate
o Ability to Prioritize, Align and Simplify
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.
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Visa sponsorship is not available for this position.
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Job: Supplier Dev & Perf Mgmt
Other Locations: DeSoto, KS, US; Elkhorn, NE, US
Employee Status: Regular
Travel: Yes, 25 % of the Time
Number of Openings: 2
Shift (if applicable):
Company Trade Name: Merck