Quality / Supplier Quality Engineer

RICHARD BAUMAN

***** ** ****** *****

Warren, MI 48088

Cell# 586-***-****

************@*****.***

SUMMARY:

Majority of career experience has taken place during new product launch phases. APQP involvement has typically focused on suppliers providing compliant PPAP documentation & verifying sample part acceptability (when required). Involvement in supplier development (especially recently with medical suppliers), understanding the importance of why PPAP information (FMEA's, Capability Studies, GR&R's, etc.) is needed, how to generate it & how to maintain it moving forward.

Have an equal amount of experience addressing nonconformities encountered through prompt issuance of CAPA's / SCAR’s / CAR's & 8D's to ensure quick containment, using root cause analysis tools to quickly identify root cause(s) & verifying permanent, effective corrections are implemented and maintained.

Work experience encompasses a variety of duties including:

Quality & Supplier Quality Engineering

Process Engineering / Auditing

EU MDR / Product Launch Engineering

Supervision / Production Management

Training / Systems Integration

PROFESSIONAL EXPERIENCE:

Zimmer Biomet, Dover, OH 7/19-12/19

Operations Quality Engineer

Created Manufacturing Summaries for production parts involved in the transition from EU MDD 93/42/EEC to meet EU MDR 2017/745 compliance requirements. Manufacturing Summaries define the specifications and materials to be used when handling and preparing product for transport throughout the manufacturing areas as well as procedures used to sanitize contact surfaces. Specifically, summaries include reference to applicable specifications, manufacturing processes & their validations, continuous monitoring, an itemized description & risk assessment of manufacturing material (adjuvants) product is exposed to & final product testing information. Provided Technical Documentation & General Safety and Performance Requirements (GSPR) information based on specifications provided in Annexes I, II and III of the EU MDR 2017/745.

Also created Manufacturing Summaries, Tech Doc’s & GSPR information for Zimmer’s sister plant in Riverside, MO.

Participated in weekly EU MDR meetings to address any manufacturing operation concerns.

SAF-HOLLAND, Dumas, AR 9/18 –4/19

Quality/Supplier Quality Engineer

Created, rewrote & continually improved work instructions, control plans, PFMEA’s, PPAP’s & in-process inspections.

Issued & responded to CAR’s, posting Quality Alerts, training personnel, poke-yoking various operations & working with SAF’s largest customer establishing a timeline to exiting CS2.

Participated in daily status & MRB meetings to address quality concerns.

Processed daily scrap reports for pareto charts, root cause analysis and inventory control.

Worked with management generating presentations depicting how company is controlling operations, continuously improving & on-track to achieving ISO/IATF certifications.

NYPRO HEALTHCARE (A JABIL COMPANY), Auburn Hills, MI 1/17 – 4/18

Supplier Quality Engineer

Reviewed & approved Medical Production Part Approval Packages (MPAP’s) submitted by vendors throughout launch of several types of Johnson & Johnson sterilization units used in hospitals worldwide.

Reviewed & approved MPAP’s (Medical Production Part Approval Packages) submitted by vendors for a new Johnson & Johnson product line (now Jabil’s largest line).

Issued 8D’s to suppliers for nonconforming issues & follow up to achieve successful resolution. MPAP as well as 8D requirements were new to most suppliers. Provided training as needed to help suppliers understand how to create/maintain required documentation & how to use root cause analysis tools to problem solve & achieve permanent corrective solutions.

Participated in daily status & MRB meetings to address quality concerns.

Reviewed PPAP’s & addressed quality issues involving various other Jabil product lines for Smith & Nephew, EES, John Deere, ArthroCare, Big Belly, Christie, Phoenix, Siemens, Stryker & others.

Issued & followed up on CAPA’s/8D’s to suppliers as needed.

Worked closely with management, engineering & shop floor personnel to resolve internal quality issues.

PHILIPS MEDICAL SYSTEMS, Cleveland, OH 6/14 – 12/15

Supplier Quality Engineer

Reviewing & approving Supplier Product Qualification (SPQ) packages submitted from vendors throughout remediation re-launch of various iCT & MRI product lines. Philips voluntarily shut down production after FDA violation findings. SPQ packages (depending on risk level) contain first article, certs (material, RoHS), GR&R study, special process validation, control plan & FMEA.

Daily status meetings to address any quality and/or delivery issues associated with various supplier products.

Participated in MRB meetings & submitted 8D’s as needed to address quality issues.

25% travel to supplier sites to provide on-site technical support including 2 months spent at a local gear supplier who was developing various complex gears used in Philips MRI units.

SPQ & 8D requirements were new to most suppliers. Conducted training as needed to help understand how to generate required SPQ documentation and resolve 8D issues with permanent corrective fixes.

Continued on-site support and training until Philips eventually achieved FDA compliance & resumed production.

KOBELCO (A CASE NEW HOLLAND COMPANY), Calhoun, GA 4/12 – 10/13

Quality/Supplier Quality Engineer

Reviewed & approved Initial Sample Inspection Reports (ISIR's) submitted from vendors throughout 5 new successful product line (heavy-duty bulldozer) launches.

Worked closely with management & engineering to quickly address & resolve quality issues which could affect the launches.

Issued 8D’s as needed to quickly resolve quality issues and ensure permanent corrections achieved.

Participated in daily launch & MRB meetings.

Represented quality on the floor during assembly of first-build production units & participated in follow-up review meetings.

Supervised all quality inspections.

CASE NEW HOLLAND, Racine, WI 4/10 – 12/11

Supplier Quality Engineer

Reviewed & approved Initial Sample Inspection Reports (ISIR's) submitted from vendors throughout 2 new successful product line (heavy-duty tractor) launches.

Worked closely with management and engineering to quickly address & resolve any quality issues which could affect the launches.

Issued 8D’s as needed to suppliers to quickly resolve quality issues and ensure good product.

Participated in daily launch & MRB meetings to address any quality concerns with product.

Represented quality on the floor during assembly of first-build production units & participated in follow-up review meetings.

Submitted Layout Requests for new product sample submissions, addressed any quality issues found & worked with the supplier to get it permanently resolved.

Trained & supervised 4 additional quality engineers hired temporarily to help process ISIR's & meet launch deadlines.

In charge of generating all charts/graphs for quality manager to use in daily presentations.

TEREX AMERICAN-CRANE, Wilmington, NC 2/08 – 12/09

Quality/Supplier Quality Engineer

Provided technical support to suppliers as needed to improve product & quality systems.

Investigated internal nonconformities and worked to error-proof internal mistakes.

Daily MRB meetings followed up with root cause investigations of both internal & external quality issues (working with suppliers) to achieve permanent corrective solutions.

Team leader conducting follow-up audits to verify corrective action effectiveness.

Team leader in numerous Kaizen events to improve efficiency in various departmental areas.

Generated all charts/graphs for quality manager to use in monthly quality meeting presentations.

PLASTECH, Monroe, MI 5/07 – 11/07

Launch Readiness Quality Engineer

Addressed and closed prevailing 8D’s, performed internal audits & implemented a robust quality system to support a new product launch for Chrysler.

Trained & motivated employees on sustaining the improved quality system & how to maintain it after launch team leaves.

Conducted periodic follow-up audits to verify quality system implementation effectiveness.

PRODUCT ACTION INTERNATIONAL, Warren, MI 2/05 – 12/06

Operations Process/Supplier Quality Engineer

Performed on-the-job process analysis to facilitate continuous improvement and increase the robustness of inspection and rework processes in operations.

Worked on 8D follow-up involving proactive sort, rework, CS1&2 (GM) and 3CPR1&2 (Chrysler) projects at various OEM, sequencer & supplier locations. Offered technical support to quickly identify, contain & resolve quality issues using root cause analysis and various problem-solving techniques. Verified effectiveness before closing 8D’s.

Performed preventive risk assessments at various locations across SE Michigan involving critical, high-risk operations. Recommended improvements as needed.

Conducted internal audits to continuously improve the quality systems and maintain ISO registration.

Conducted CS2 & 3CPR containment kickoff meetings at various Tier 1 & 2 automotive suppliers.

Provided engineering support/training on error proofing techniques, gage selection & use, fixtures and tools, inspection methods, standardized work, labeling, packaging & shipping.

Participated in team meetings with automotive, government & military personnel addressing various design & quality issues encountered during various product launches.

EDUCATION:

MS Production & Industrial Operations Management, Lawrence Technological Institute, Southfield, MI

ASQ Scholarship Award for Graduate Studies, ASQ Society, Akron-Canton Section

BS Automated Manufacturing Engineering Technology with Minors in Business Management, Liberal Arts & Drafting Technology, University of Akron, Akron, OH

TECHNICAL SKILLS:

Software: Windows 7, 8.1, 10, ’98, XP & Vista, Office 2000, 2013, 2016 & 365. G&M code and APT part programming, MPACT, SIMFACTORY, Covisint (Chrysler), Front Page, GagePak, MS Project, AS-400, WPS, Paint Shop Pro, AutoCAD LT, MiniTab, Smartsheet, SAP & Livelink.

Programmable Automation Systems: Various CMM, CNC machines & robotics made by ABB, Brown & Sharpe, Cincinnati Machine, Comau-Pico, Durr, Fanuc, Giddings & Lewis, Hardinge, Landis, Raytheon, Schenck, Valenite & many others.

Quality Assurance: EU MDR Manufacturing Summaries, Work Instructions, APQP, MPAP & PPAP documentation (Process Flow, FMEA’s, Control Plans), QSB, GD&T interpretation, GR&R studies, JIT, CAR’s, CAPA’s & 8D Reporting, FAI, ISIR, MRP, MRB, Six Sigma, SPC, GSPR, Root Cause Analysis, Internal & Supplier Training, Labeling, Risk Assessments, Lean Manufacturing, GM’s Foundations & Applications, ISO/QS 9000 & 13485, TS 16949, GM 3rd Party Containment Meetings & follow-up Corrective Action Assessments, SCR/ECN, FDA 21 CFR Part 820 (GDP & GMP), SPQ, PSV, 5S, QMS, RMA, Supplier DPM, Project Engineering, Kaizen, 1st Piece Inspection, Internal / Supplier / Layered & Kami Shiba Audits.

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