Skills:

MS Office/Excel, Visio, PowerPoint, Pivot Tables, Charts. SharePoint, Teams. WMS, IFS, SAP, 3pl Central/Qcloud.

* ***** ******* ********* ** industry standards, FDA regulations, and guidelines (e.g., ISO 9001:2015,ISO 13485:2016 Medical Device, ISO 2200)

In-depth knowledge of Lean Six Sigma methodologies (i.e., Define, Measure, Analyze, Improve and Control (DMAIC), Design for Six Sigma (DFSS), Lean Process Improvement.

4 years hosting audits, internal and external, ISO, AIB, SQF, cGMP Internal

Picker and forklift

Education:

BBA: Bachelor of Business Administration/Management Sep 2007- May 2011

University of Toledo, Toledo, OH

Work Experience:

Go Direct Solutions, Groveport, OH – Fulfillment Jun 2022 - Current

Quality Manager:

Providing guidelines and direction to all Departments (GMP, WI & SOP, and Flow Charts) assist in meeting departmental requirements for respective departments. Internal Failure, KPI Tracking, Health & safety, etc.

Manage quality department personnel (QC Supervisor and QC Auditors) in their activities to meet department/company objectives.

Ensure through leadership staff that all operations associates are developing the needed skills, receiving training, Development that is consistent with their responsibilities (Quarterly and annual training per training matrix).

Manage document control requirements. Create and manage document indexes. Provide direction to all departments regarding SOP, WI creations are aligned with GDA’s required formatting.

Conduct and host risk/severity assessment group review with eternal team and customer.

Manage and conduct internal medical device audits. Plan internal audit schedule. Ensure alignment with all ISO clauses and sub clauses. Host second (Customer) and third-party audits (ISO 9001, 2200, 13485 Lead Auditor training – current standards).

Conduct and host team review of all SCAR’s, customer required corrective actions through a root cause investigations using 5why, Fishbone, Brainstorming to ensure effectiveness check success.

Align and host management for quarterly management review.

Walton Plastics, Walton Hills, OH - Plastic Extrusion Nov 2020 – Jun 2022

Quality Manager:

Development, implementation, maintenance, monitoring, measurement, and continuous improvement training of the Quality Management System (QMS), organization and manage staff on quality control and analytical procedures.

Manage internal audit schedule and external (Customer).

Provide guidelines and direction to all departments (GMP, WI) assist in meeting departmental requirements for respective departments (Internal Failure KPI Tracking, etc.

Manage quality department personnel (QC Tech) in their activities to meet department/company quality objectives.

Ensure all operations associates are receiving proper training and development consistent with their responsibilities (Annual training).

Meet with vendors, customers, quality representatives, and company personnel to discuss and resolve quality problems (CAPA, RCA, 8D, 5 Why).

Keep the Quality Director informed of department activities and the progress of

meeting objectives.

Impact Fulfillment Services, Columbus, OH - Fulfillment Nov 2019 –Nov 2020

Quality Manager:

Development, implementation, maintenance, monitoring, measurement, and continuous improvement training of the Quality Management System (QMS), organization and manage staff on quality control and analytical procedures.

Administer key QMS and food grade business processes (FDA, HCCAP) and manage medical device internal Audit Schedule and external second-and third-party audits (External, ISO 13485).

Responsible to provide guidelines and direction to all Departments (GMP, WI and SOP’s), assist in meeting departmental requirements for respective departments (Internal Failure, KPI Tracking, etc).

Responsible for management of the quality department personnel (QC Supervisor and QC Auditors) in their activities to meet department/company objectives.

Ensure operations associates are developing needed skills and receive training and development consistent with their responsibilities (training).

Meet with vendors, customers, quality representatives, and company personnel to discuss and resolve quality problems (CAPA, RCA, 8D, 5 Why).

Keep the General Manager informed of department activities and the progress of meeting objectives.

Columbia Packaging Group Inc, Cambridge, OH – Plastic Extrusion Nov 2018 - Nov 2019

Quality Manager:

Create, Standardize, and maintain QMS for all departments following ISO 9001 standards

Ensure strict compliance with Quality Management System is followed in all phases of production.

Train and manage staff on quality control and analytical procedures.

Collect and analyze production samples to evaluate quality.

Stop production if serious product defects are present.

Ensure all products that are scheduled to leave the company meet the quality specification and customer standards.

MS Companies, Toledo, OH – Automotive Quality Aug 2014 – Nov 2018

Regional Quality Supervisor/ Warehouse Manager:

Manage staff on quality control and analytical procedures.

Ensure strict compliance with quality system is followed in all phase of manufacturing, Quality Inspection, GP12 Launches.

Ensure all products that enter and leave the company meet the quality specification standard.

Collect and analyze production samples to evaluate quality.

Stop production if serious product defects are present.

Using ISO standards review and update standard operating procedures, including work instructions and sort standards.

Review quality documentation necessary for regulatory submissions and inspections.

Discuss inspection results with those responsible for products and recommend necessary corrective actions to the teams.

Produce reports regarding nonconformance of products or processes, daily production quality, root cause analysis, or quality trends.

Responsible for multiple locations (3) throughout Ohio managing 35 Direct reports, with the largest facility being about 400 employees.

Warehouse Manager:

Prepare documents, such as work orders, bills of lading, or shipping orders, to route materials.

Pack, seal, label, and affix postage to prepare materials for shipping, using work devices such as hand tools, power tools, and postage meter.

Examine contents and compare with records, such as manifests, invoices, or orders, to verify accuracy of incoming or outgoing shipment.

Weigh materials or products and record weight or other production data on tags or labels.

Record shipment data, such as weight, charges, space availability, damages, or discrepancies for reporting, accounting, or record keeping purposes.

Direct inbound or outbound logistics operations, such as transportation or warehouse activities, safety performance, or logistics quality management.

Manually or mechanically load or unload materials from pallets, skids, platforms, cars, lifting devices, or other transport vehicles.

Compute amounts, such as space available, shipping, storage, or demurrage charges, using computer or price list.

Perform Technologies, Swanton, OH – Plastic Injection Molding May 2012 – August 2014

Press Operator:

Perform minor machine maintenance, such as oiling or cleaning machines, dies, adding coolant to machine reservoirs.

Load work pieces, plastic material and chemical solutions into machines.

Calibrate and adjust equipment to ensure quality production.

Start machines, monitor their operations, and record operational data.

Extract or lift jammed pieces from machines, using fingers; wire hooks, or lift bars.

Inspect finished products for quality and adherence to customer specifications.

Bulk Molding Compounds – Perrysburg, OH August 2008 – May 2012

Extruder Cutter Operator/Shipping and Receiving:

Obtain customer names, addresses, and billing information, product numbers, and specifications of items to be purchased, and enter this information on order forms.

Prepare invoices, shipping documents, and contracts.

Inform customers by email or telephone of order information, such as unit prices, shipping dates, and any anticipated delays.

Receive and respond to customer complaints.

Verify customer and order information for correctness, checking it against previously obtained information as necessary.

Direct specified departments or units to prepare and ship orders to designated locations.

Check inventory records to determine availability of requested merchandise.

Review orders for completeness according to reporting procedures and forward incomplete orders for further processing.

File copies of orders received, or post orders on records.

Compute total charges for merchandise or services and shipping charges.

Adjust inventory records to reflect product movement.

Notify departments when supplies of specific items are low, or when orders would deplete available supplies.

Extruder Cutter Operator:

Read work orders or production schedules to determine specifications, such as materials to be used, cutting locations, dimensions, tolerances and quantities to cut.

Test and adjust machine speeds or actions, according to product specifications, using gauges and hand tools.

Load plastic material and chemical solutions into machines.

Set blade tensions, heights, and angles to perform prescribed cuts, using wrenches.

Turn controls to set cutting speeds, feed rates, or table angles for specified operations.

Measure test cuts to verify conformance to specifications, using micrometers, gauges, calipers, templates and rulers. Count, weigh and bundle items.

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