Quality Engineer

The Quality Engineer is responsible to improve process capability with regards to evaluating statistical data analysis and implementing corrective action to achieve plant KPI indicators. Also responsible for issuing, maintaining, controlling, and auditing documentation required for Technical Transfer, Validation and Management of Change.

Tech Transfer / Plant Testing: Site responsibility to manage Technical Transfer Quality Standard.

-Perform Process Capability Quarterly Statistical Analysis for new and modified products and communicate to R&D for process improvement. Use of Minitab

-Active participation in project meetings to provide input on requirements and pending activities to comply with project execution.

-Complete pre launch related tasks to QE during tech transfer transition.

-Complete EMO checklist related tasks before test execution.

-Create and follow up on the post launch checklist as per required for all formulas implemented at the site.

-Set up SAP master data, inspection plans(packaging), BOM management, ECN creation(if applicable), input formula into BOM for costing.

-Create size type groups to define product weight for manufacturing

-Leads EMO plant testing for new products/RMQ and new products execution(perform EMO report if not R&D present).

-Configure OPERA for new SKUs and create new groups for new sizes and upcoming changes.

-Coordinator of the component alignment process for new labels.

-Review new labels and upload label image in SAP for WH release.

-Create inbatch recipes for all formula changes required as per product grid implementation.

-Create batch cards for all changes required as per product grid implementation

-Coordinate and send samples of validations and new products for stability.

Management of Change:Site subject matter expert for Management of Change standard.

-Create formula changes MoC and follow change as coordinator.

-Follow up on MoC approvals and closure (includes assign tasks manually, assign owners).

Process Validation & Control: Oversees the validation program, conducts risk analysis, maintains and updates validation master plan, develops validation protocols for PPQ, supports IQ/OQ & PQ in conjunction with the engineering team.

-Collect FP validation reports and create final validation reports.

-Assign validation document numbers to the site.

-Create risk assessment for all formula projects.

Product Conformance:Coordinate and follow up non conformances to comply with product conformance standard.

-Open NC in SAP system and communicate with operations of open NCs.

-Review failure investigation drafts Create inspection/rework protocols for non conforming products.

-Reconcile inspection/rework protocols for accuracy.

-Follow up non conformance closure for less than 30 days.

-Review and draft notice of deviations and route them for approval.

-Follow up on Z1 notifications for closure and inspections needed.

-Foloow up on preventive and corrective CAPAs from related non conformances.

-Open non conformances for packaging material complaints and communicate it to suppliers.

-Follow up on CAPA response from material supplier.

-Block non conforming material if needed.

-Coordinate suppliers visit if required.

-Create scrap orders for non conforming materials and follow up on scrap execution with CBS group.

-Coordinate and investigate customer complaints from finished products.

Others: Requests samples for operations and coordinates communication between WH and plant. -Creates protocols for Z1 reports. -Support WH on corrections on MIGO materials. -perform training on the shop floor as required. -Update SOPs as part of the Documentation standard. -Supports R&D/Operations when required for formula or plant related questions

Required Qualifications

• Bachelor's Degree in Chemistry, Engineering, Biology, Food Science or other related field
• At least 2 years related manufacturing experience

Preferred Qualifications

• At least 2 years related Quality related experience
• Knowledge of HACCP, Food Safety, FSMA
• Knowledge of Colgate Quality standards and Systems
• Knowledge of 6 Sigma / Lean Manufacturing
• Working understanding of SAP / Minitab
• Prior participation in auditing programs