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Engineer Quality

Location:
Redford Charter Township, MI, 48240
Salary:
820000
Posted:
April 16, 2012

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Resume:

EXPERIENCE

Xoran Technologies- Ann Arbor, MI. Oct. 2011 to Present

Sr. Quality Engineer

• Performed root-cause investigations related to product or processes complaints for CT scanners. Worked with investigation owners to ensure identification of root cause.

• Reviewed and approved device manufacturing records to insure completeness and accuracy.

• Supported Customer Service and Operations groups in developing SOPs and Work Instructions based on quality plans and other technical information provided by Engineering.

• Developed and maintained nonconforming procedures and work instructions. Lead non-conforming part reviews, investigations, and follow-up actions.

• Lead supplier quality assessment activities, including new vendor approval, facility audits, first piece approvals, and corrective action plans. Worked with suppliers to resolve supplier related non-conformances

• Developed and maintained calibration procedures and work instructions. Coordinated the calibration process with gage owners and calibration subcontractor to ensure timely calibration.

• Developed process validation protocols for review / approval by management. Executed approved protocols and generated validation report.

• Implemented metrics to monitor quality system, manufacturing & supplier performance

• Participated in design reviews of products & processes to ensure all required quality/ design tasks are completed prior to signoff of phases.

• Participated in design transfer of products & processes to ensure all required quality tasks are completed prior to transfer to operations.

• Developed the risk management plans, hazard harm analysis plans, and quality plans for CT scanners to ensure compliance to the FDA.

• Developed the template for the DFMEA and PFMEA for CT scanners to ensure compliance to the FDA.

• Responsible for ensuring Xoran complied with the Quality System but not limited to developing PFMEA, DFMEA, Sampling plans, Control plans, Validation Qualification ( Installation, Operational and Performance) and process flows.

• Reviewed and sign-off on product and manufacturing process changes for compliance with applicable regulations.

• Ensured compliance with both organizational objectives and relevant regulatory requirements are maintained including US FDA Quality System Regulation (QSR)/Good Manufacturing Practices (GMP), ISO 13485, ISO 14971, European Medical Device Directive (MDD) and Xoran Quality Manual.

• Lead and conducted engineering quality activities such as Failure Mode and Effects Analysis (FMEA), product verification, design and process validation, failure analysis, hazard analysis, authoring test plans and reports, developing and implementing quality inspections, determining sample sizes and Design of Experiments (DOE).

• Conducted internal and external quality audits.

• Lead CAPA and MDR investigations.

• Supervised/Mentored quality engineers and hourly quality techs in the quality area.

• Responsible for quality aspect from the cradle to the grave.

Nissan- Farmington Hills, MI. Feb 2011 – Oct, 2011

Contract Sr. Advanced Quality Mechanical Engineer

• Responsible for new product designs and the processes for manufacturing exterior and interior highly visible components to meet all Corporate and Divisional quality requirements with respect to safety and efficacy.

• Experienced in Quality Engineering discipline including design controls, product/process validation, supplier management, and technical problem solving.

• Used an appropriate level of competence in Quality Technology including statistical techniques and six sigma tools including sampling plans, process capability analysis, gage R&R, hypothesis testing, analysis of variance, regression, and design of experiments.

• Improved and assured trial VC Lot part and vehicle quality with the use of the APQP

• Conduct problem solving activities that drive continuous improvement efforts and quality improvements to the final customer.

• Confirmed suppliers adopted all design requirements into their quality control plan,

• Improved quality capability by balancing vehicle structure standardization and part structure optimization

• Confirmation of vehicle assigned parts

• Provided technical direction on problem parts and overall management of the suppliers tasked to follow

• Oversaw production, installation, operations, maintenance and repair of such equipment

• Handling multiple quality related projects simultaneously.

• Working closely with internal and external customer and suppliers to troubleshoot problems and provide onsite visits to investigate problems.

TransNav - New Baltimore, MI Aug 2010 – Jan 2011

Lead Plant Quality Mechanical Engineer (Contract)

• Acted as official backup for Plant Quality Director

• Coordinated plant scrap reduction efforts, including the summarization of plant yield performance, departmental scrap reduction goals, & projects and early warning response to high scrap events.

• Provided timely investigation, response, & follow up to product quality issues, manufacturing concerns/complaints or requests related to product information & incoming inspection for outsourced components. This included keeping the product hold area current, providing data analysis, root cause problem solving for corrective & preventative action, as well as timely/accurate reporting to plant leadership.

• Developed operating procedures & work instructions as related to process and procedure improvement efforts.

• Provided day to day technical directions & training to all levels of plant personnel (product line manager, plant management, supervisors, and production control) regarding standard engineering techniques, procedures and criteria for problem solving of technical issues related to process control, gaging, & inspection criteria.

• Lead and coordinated plant machine capability and gage R&R programs.

• Lead and coordinated PPAP, PSO, GR&R, capability, and APQP.

• Assisted in developing capable manufacturing processes for new and improved products and or processes and manufacturing cost reduction in injection molding manufacturing.

• Developed and maintained open communication to effectively resolve issues related to the quality system. This included not only local operations and associates, but also customers and suppliers.

• Responsible for ensuring TransNav complied with the Quality System but not limited to developing PFMEA, DFMEA, Sampling plans, Control plans, Validation Qualification ( Installation, Operational and Performance) and process flows.

• Developed SPC requirements for new product.

• Responsible for root-causing issues (8D’s and CAPA) associated to complaints received (in-house and at the supplier base).

• Supervised /Mentored quality engineers and hourly quality techs in the quality area.

Stryker Instruments - Kalamazoo, MI Oct 2008 – Aug 2010

Sr. Staff Advanced Quality Mechanical Engineer/Supplier Development Engineer

• Responsible for the development and implementation of quality assurance practices and controls in new product development

• Provide guidance to product design development teams as to the required deliverables to ensure compliance throughout design development cycle.

• Provide guidance on design control and standards to the development teams.

• Review, assess and approve design milestones and deliverables throughout design development cycle to ensure compliance.

• Participate in development of specifications including definition of user needs.

• Develop test strategies, and participate in design verification and validation tests.

• Generate metrics for assessing quality and evaluate results.

• Participate in critical analysis, design, and change review meetings.

• Supplier Development responsible for ensuring suppliers comply with the Quality System but not limited to developing PFMEA, DFMEA, Sampling plans, Control plans, Validation Qualification ( Installation, Operational and Performance) and process flows.

• Facilitate and approving suppliers PPAP submission for production ready components.

• Developing SPC requirements for new product.

• Responsible for root-causing issues (4D’s and CAPA) associated to complaints received (in-house and at the supplier base).

• Responsible for supplier audits of new products.

• Responsible for educating and development of supplier for PPAP, PSO, GR&R, capability, and APQP.

• Responsible for Validation and Verification at supplier base for new product.

• Assist engineers/operational quality/compliance representatives to identify compliance/quality risks during the design development cycle.

• Contribute to process improvements by developing and/or updating written company or departmental procedures related to design development.

• Oversee design requirement management process, configuration management process and defect tracking process.

• Support outsourced vendor audits and qualifications, assist in product acquisitions.

• Supported the following programs: Disposable gowns, disposable hoods, FLYTE equipment, RemB( surgical power tools), Sag saws, Sterum blades( long and short), cathers, pain pumps, SABO ( micro battery powered rotary small handpiece), CB3 (micro battery powered sag hand piece) , sterilization cases, System 7, Steri-Shield, and blood pressure cuffs.

• Supervised and mentored quality engineers

SALEEN INC. Troy, MI. March 2008 - June 2008

Sr. Body Design Engineer

• Designed grilles, fascia, rear bumpers, front bumpers, body side moldings, wheel liners, side rockers, badges and appliqués for aftermarket customers.

• Designed B-side attachment of body kits for aftermarket installation.

• Worked directly with Design Studio for design feasibility.

• Supervised contractor work internationally and domestically.

• Procured mechanical parts needed for car and minivan exterior installations.

• Created and updated drawings, trees and models by CATIA V5.

• Feased out studio design for product compliance to customers and industry engineering standards.

• Interacted with Automotive suppliers and Tier 1's for mechanical and appearance approval.

• Performed Material Specification for plastic parts, rubber parts, and paint for aftermarket customers.

• Performed Analytical analysis, DOE's, Quality Control, and Root Cause Analysis.

• Created and maintained engineering documents to meet quality system requirements for DFMEA, PFMEA and design review documents.

• Proficient in writing compliance reports for exterior components to government regulations.

• Performed chalk studies, modeling studies, RSS (Root of the Sum of Squares) studies, and stackups.

• Wrote compliance reports for exterior components to government regulations.

• Responsible for choosing correct plastic materials for components

• Responsible for design and repeatability of tooling for plastic components.

• Oversee all aspects of the program i.e. budget, timing, tooling, testing, models and prototype parts.

DaimlerChrysler Auburn, MI (Contract) October 2002- March 2008

Product/Release Engineer for Exterior Systems

• Designed grilles, brackets (fascia, grille, sensor, license plate), hood shields, badging, lighting (headlamps, tail lamps, CHMSL, license plate), fascia, rear bumpers, front bumpers, step supports, body side moldings, wheel liners, splash shields, spats, appliqués and or any exterior systems for domestic and international markets.

• Designed wire harnesses and rear back up sensors for rear fascias and bumpers.

• Designed washers systems for front fascias.

• Supervised contractor work internationally and domestically.

• Procured mechanical parts needed for Truck and Jeep exterior installations.

• Updated drawings, trees and models by CATIA V-4

• Interacted with Automotive suppliers for mechanical and appearance approval.

• Performed as Liaison for Germany to interact in the American market place for the Sprinter vehicle.

• Provided GD&T application to automotive models.

• Performed Material Specification for plastic parts, rubber parts, and paint for DCX.

• Performed Documentation Specification for internal and external customers in English and German

• Supervised required labs for DCX's mechanical testing specifications.

• Worked directly with supplier's release engineer to get models into the DCX system.

• Released drawings in both Catia and VPM format.

• Preformed PPAP, PSO's, PER's, DFEMA's, and QS-9000 procedures.

• Performed Analytical analysis, DOE's, Quality Control, and Root Cause Analysis.

• Performed chalk studies, modeling studies, RSS (Root of the Sum of Squares) studies, and stackups.

• Completed assignment as MCM (cost savings) lead for the lighting and grille group.

• Completed assignment as MCM (cost savings) team member for wipers and mirrors.

• MCM (cost savings) team member for Front and Rear Bumper, Grilles, Fascias, and Exterior Ornamentation

• Oversee all aspects of the program i.e. budget, timing, tooling, testing, models and sample parts.

• Proficient in writing business cases to support cost saving ideas.

• Proficient in writing compliance reports for exterior components to government regulations.

HARMAN/BECKER AUTOMOTIVE SYSTEMS, Farmington Hills, MI November 2000 - October 2002

Sr. Mechanical Design Engineer

• Designed navigation radios and bezels for domestic and international markets.

• Designed lighting piping, faceplates, fans and switches for navigation radios in the domestic and international markets.

• Performed paint studies for appearance requirements.

• Supervised contractor work internationally and domestically. Design/Product/Release

• Procured mechanical parts needed for radio installations.

• Updated drawings by CATIA V-4/PRO-E.

• Interacted with Automotive Customers for mechanical and appearance approval.

• Performed as Liaison for Germany to interact in the American market place.

• Provide GD&T application to radio models.

• Perform as Data Acquisition and interpretation for Root cause analysis.

• Performed Material Specification for plastic parts, aluminum parts, rubber parts, paint and fans for OEM's and aftermarket.

• Perform Documentation Specification for internal and external customers.

• Complete Drawing conversions.

• Supervised required labs for OEM's mechanical testing specifications from customer.

• Worked directly with customers release engineer to get drawings into the DCX system.

• Released drawings in both Catia V-4 and VPM format.

• Released in different areas (i.e. Mailbox or directly into the system)

• Utilize PPAP, DFEMA's, and QS-9000 procedures.

• Perform Analytical analysis, DOE's, Quality Control, and Root Cause Analysis.

• Perform chalk studies, modeling studies, RSS (Root of the Sum of Squares) studies, and stackups.

EAI, Southfield, MI (On loan to DaimlerChrysler) October 1998 - July 2000

Dimensional Management Engineer

• Provided staff support to plant Supervisors, QA Managers, Steering Committees, and others in the application of Dimensional Control and SPC methods.

• Performed Analytical analysis, DOE's, Quality Control, and Root Cause Analysis.

• Provided CAD support in Catia.

• Provided GD&T application and 3-D Variation Analysis on the instrument panel, HVAC unit, underbody hoses, steering column support, compressors, air ducts, doors, interior trim in Catia.

• Performed chalk studies, modeling studies, RSS (Root of the Sum of Squares) studies, stackups.

• Oversaw gage studies with suppliers.

• Created and managed templates data analysis in Catia.

• Provided VPM and Catia Management.

• Built Objective Management.

• Performed Data Acquisition and interpretation.

OWENS ILLINOIS, Toledo, OH August 1996 - October 1998

Statistical Process Control Coordinator (SPC Coordinator) 12/97-10/98

• Provided staff support to plant SPC Supervisors, QA Managers, SPC Steering Committees, and others in the application of SPC methods.

• Assisted Customer Service Engineers and Sales personnel in the presentation of SPC information to customers.

• Conducted in-plant training at Owens-Brockway and TA plants in gauge usage, SPC computer program usage, and application of data.

• Assisted and developed new applications for SPC techniques.

Project Engineer 8/96-12/97

• Designed electrostatic precipitators for domestic and international glass plants.

• Provided water-balancing surveys for domestic and international glass plants.

• Designed forehearths, refiners, alcoves and combustion skids for glass plant.

• Designed fans for stack and cooling wind applications.

• Designed cooling towers for domestic and international glass plants.

• Supervised contractor work.

• Procured mechanical parts needed for machine installations.

• Updated drawings by utilizing MicroStation.

• Developed team work ethics.

EDUCATION:

B.S. TUSKEGEE UNIVERISITY, MECHANICAL ENGINEER

TECHNICAL SKILLS

Knowledge of Plastics: ABS, Polycarbonate, PC-ABS, TPO, PC/Acrylic Alloy, PC/PBT Alloy, TPE, Polypropylene, Polyurethanes, and HDPE (High Density Polyethylene). 14 years Experience.

Knowledge of Molding Processes: Injection molding (including 2 shot), Blow Molding, Vacuum Forming, and Extrusion. 14 Years experience

• 7 years experience in CatiaV4

• Trained in V5

• FORTRAN

• Project management

• Minitab

• AutoCad

• Catia V-5

• PRO-E

• VPM

• Visio

• ANPQ

• GD&T

• Excel

• Six Sigma

• PowerPoint

• ANPQP

• Word

• Gage design

• QS-9000

• TS-16949



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