NEIL IGLINSKY

• Assist and help implement Risk Management Plans (dFMEA) with core team members throughout the different phases of the project.
• Developing MSA budgets for projects. In addition, researching and developing project CER (Capital Expense Request) for inspection gaging capital includes providing updates to the financial group on when gages are in service.
• Review and approve drawing prints with manufacturing support.
• Review/approve the following documents: Product Specifications, Packaging Validations, Label approvals in Matrix, CERs (Clinical Evaluation Reports), and supplier validation protocols/reports.
• Work with internal or external suppliers in developing the inspection methods, MSA (GR&R) activities, capability studies, and any validation work.
• Work with internal resources in designing gages, along with getting quotes from suppliers in order to generate purchase order requisitions.
• Track all overlays, gages needed for the project; review and approve all overlay drawings and gages procured internally or through gage suppliers.
• Initiate calibration inspection plans through the Metrology department, and write rationales within SAP for calibration results.
• Responsible for initiating ECRs for any connections within Matrix, or any changes to gage prints, overlay drawings, or inspection drawings.
• Write MSA protocols/reports, process characterization protocols/reports, and PQ protocols/reports.
• Involved with researching historical complaints in order to generate occurrence rankings within the dFMEA. In addition to researching history complaints, the results are used in writing history complaint memos, and stored within Matrix.
• Work closely with Product Development, Manufacturing, Packaging, Project Manager, and suppliers involved with the project.
• Develop and train inspectors to meet any visual standards developed.
• Responsible for completing all QIRs at the CI level and O/MFG numbers at the Memphis and GDC locations.
• Responsible for setting up and driving the Functional/Pre-Release Audits of all components going through the Design Transfer process.
• Responsible for working with the internal and external suppliers in generating the Control Plan, along with reviewing the Macro Map, Detailed Process Map, and pFMEA with the Manufacturing Engineer.
• Involved with supplier audits and any internal audits (i.e., Corporate, process validation, FDA, BSI, etc.).
• Removing quality holds within SAP.
• Develop, execute, and analyze correlation inspection studies between the supply base and the R/I facility.

Quality engineering support for manufacturing and project management. Develop inspection requirements, facilitate pFMEAs, resolve discrepant material issues, and create and maintain quality documents, such as control plans and inspection plans.

Analyze data for inspection frequency reduction for capability studies, along with MSA studies (Gage R&Rs), and identify improvement opportunities.

Work with engineering and manufacturing to implement effective inspection and control plans for new product development.

As the quality interface for a production team in responding to customer complaints, using failure analysis, the development of corrective and preventative actions, and trend analysis.

Support the quality inspectors to ensure that inspection plans comply with the relevant requirements of the customer's product requirements.

Built a strong rapport with team members, management, and clients to facilitate efficiency and productivity.

Participating in employee performance reviews and offering suggestions to management.

Writing protocols, qualification documents, test plans, and test reports for quality assurance purposes.

• Assist and help implement Risk Management Plans (dFMEA) with core team members throughout the different phases of the project. This includes presenting the medium and high risks through SERB activities.
• Developing MSA budgets for projects. In addition, researching and developing project CER (Capital Expense Request) for inspection gaging capital includes providing updates to the finance group on when gages are in service.
• Review and approve drawing prints with manufacturing support.
• Review/approve the following documents: Product Specifications, Packaging validations, Label approvals in Matrix, CERs (Clinical Evaluation Reports), and supplier validation protocols/reports.
• Work with internal or external suppliers in developing the inspection methods, MSA (GR&R) activity, capability studies, and any validation work.
• Work with internal resources in designing gages, along with getting quotes from suppliers, in order to cut purchase order requisitions.
• Track all overlays, gages needed for the project; review and approve all overlay drawings and gages procured internally or through gage suppliers.
• Initiate calibration inspection plans through the Metrology department, and write rationales within SAP for calibration results.
• Responsible for initiating ECRs for any connections within Matrix, or any changes to gage prints, overlay drawings, or inspection drawings.
• Write MSA protocols/reports, process characterization protocols/reports, and PQ protocols/reports.
• Involved with researching history complaints in order to generate occurrence rankings within the dFMEA. In addition to researching history complaints, the results are used in writing history complaint memos, and stored in Matrix.
• Work closely with Product Development, Manufacturing, Packaging, Project Manager, and suppliers involved in the project.
• Develop and train inspectors to meet any visual standards developed.
• Disposition discrepant orders in MRB as rework or scrap.
• Work with me and production personnel to come up with countermeasures for issues on the floor.
• Responsible for completing all QIRs at the CI level and O/MFG numbers at the Memphis and GDC locations.
• Responsible for setting up and driving the Functional/Pre-Release Audits of all components going through the Design Transfer process.
• Responsible for working with the internal and external suppliers in generating the Control Plan, along with reviewing the Macro Map, Detailed Process Map, and pFMEA with the Manufacturing Engineer.
• Involved with supplier audits and any internal audits (i.e., corporate, process validation, FDA, BSI, etc.).
• Removing quality holds within SAP.

• Establishment of control plans and monitoring systems for supplier processes.
• Assist with GR&Rs, process capability studies, critical features identification through dFMEAs, and Qualifications/Process Validations (IQ/OQ/PQ). Provide technical engineering expertise and leadership to the Supply Management organization and suppliers.
• Serving as a liaison between the suppliers' capability and Medtronic's design requirements to assure that deliverables are met.
• Lead and support new product early-phase activities related to the supply base.
• Facilitate design, transfer planning, execution, and confirmation.
• Facilitate supplier meetings to cover the Design Transfer activities, which would include the growth team (Concurrent Engineer, Design Quality Engineer, Manufacturing Engineer, Procurement, and the supplier).
• Relay supply base capabilities to Strategic Procurement for inclusion within the supplier selection process.
• Coordinate the proper communication of specifications to the supply base.
• Work with Supplier Quality to ensure proper documentation is collected and stored within the quality system.
• Facilitation and reporting of the progress of supplier corrective actions.

Key Accomplishments:

• Reduced the variability of the current non-production ordering process by 15%. The previous process used to order, manufacture, and receive non-production parts was unpredictable and had too many variables, which delayed orders in meeting the expected delivery dates.
• Team member involved in updating the prototype database through a Lean Sigma project handed down by upper management. In addition, all of Product Development was trained on the new updates and requirements.

Key Accomplishments:

• Increased profit margins by 20% through designing and launching new EPA tier-level sheet metal enclosures for the industrial power units.
• Improved the functionality of the sheet metal part system by instituting a procedure on the documentation of labeling the parts.
• Standardized sheet metal design, which utilized common parts for numerous power units, therefore eliminating the need for multiple parts.

Key Accomplishments:

• Implemented changes to several manufacturing processes, which added value by decreasing scrap, and increasing profit.
• Reviewed and corrected shop-floor fabrication drawings to eliminate confusion on existing prints; as a result, the company was more efficient in planning and scheduling.

Key Accomplishments:

Incorporated new concepts and ideas through existing experience and formal technical education.