SUMMARY:

• Risk management DFMEA / PFMEA and manufacturing troubleshooting. Remediate unclear procedures and unclear requirements. Design Controls based on data not opinion.
• ISO 13485 Certified Lead Auditor. and mentoring of high risk suppliers.
• IQ/OQ/PQ process validation team leader. New product and TMV test method plans and reports. Improved trace matrix compliance tracking. Apply statistical analysis (Minitab).
• CAPA field complaint resolution. 8 - D root cause analysis problem solving.
• Hands on engineer. Continuous improvement kaizen team leader. Experience with software, plastics injection molding, CNC metal machining, finishing, PCB electronics, assembly / test.

TECHNICAL SKILLS:

Risk Assessment: QSR QMS Mitigation, FDA regulatory requirements GMP manufacturing 21 CFR 820, warning letter 483 consent decree, UFMEA gap analysis, FMECA, Design Reviews, ISO 13485 ISO 14971 risk management

Problem solving: 8-D, Red X Shainin black belt BOB and WOW, Toyota TQM total quality management, 5 WHYS, Ishikawa fishbone, Pareto analysis, 9 Windows Triz

Complaint Handling: CAPA, Class I, II, III devices, 510(k), DMR, DHF, cGMP, Clean Room, sterilization, bioburden, biocompatibility, PLM product life management, CE mark MDD 93/42 design dossier, technical fileSix Sigma Lean Manufacturing. DMAIC (define, measure, analysis, improve, control), SIPOC, PDCA, PDSAValue stream process mapping inputs / outputs, PFD process flow diagram, DOEIQ/OQ/PQ validationCSV computer system validation

Quality: MRB, Control Plan, FAI first article, FAIR, ISIR, sample size AQL, MSA measurement system analysis, calibration, CMM Metrology, validation protocols and reports, software validation, GD&T, ATMV and VTMV test method validation, QSR quality system and MDD medical device reportingISO 9000 / ISO 9001, TS16949, AS9100ISO 60601 medical electrical equipment standard, WEEE, UL CSA compliance, ISO 6 304 electrical complianceJ-Std soldering, EMC, SMT, PWB, PCBA, ISO 14001 electronics fabrication, RoHS, REACH

Design QualitySupplier Quality: CTQ dimensions and features, design controls, design verification and validation, PQP product quality plan, CpK, Cp, PpK, Pp capability studies, VOC Voice-of-Customer, PLM product life cycleSupplier evaluation, SCAR root cause and corrective actions, PPM supplier scorecard, verification of effectiveness, tracking and trending quality metrics KPIand coaching engineers, technicians, operatorsProject Management, line support, APQP, PPAP, DPV&R test plan and report

Computer programs: SAP, Agile, Windchill, ERP, IQS, IQMS, CATIA CAD, MOLDFLOW molding simulation, RJG Scientific moldingMINITAB statistics, QCcalc SPCMicrosoft MS Project, Word, PowerPoint, Excel, Office, data base management

PROFESSIONAL EXPERIENCE:

Confidential, Warsaw IN

Lead Quality Engineer

Responsibilities:

• Align supplier documentation with updated Zimmer forms and procedures.
• Review previous IQ / OQ/ /PQ validation reports for adoption.
• Train and coach 5 supplier quality engineers.

Confidential, Bothell WA

Quality Engineer

Responsibilities:

• Document inadequate execution. Simplify work instructions and forms.
• Define linkages between procedures, clarify functional role inputs / outputs.

Confidential, Colorado Springs CO

Supplier Quality Engineer

Responsibilities:

• Improved measurement best practice MSA. Reduced inspection time 25%.
• Implemented supplier correlation for successful OQ process validation.

Confidential, Danvers MA

Senior Quality Engineer

Responsibilities:

• Saved $300,000 and reduced daily MRB from 1 ½ hours to less than 30 minutes.
• Created operator Within Industry and questions for Understanding Why defects are important. Apply process mapping SIPOC and DMAIC six sigma lean manufacturing tools.

Confidential, West Chester, PA

Quality / Manufacturing Engineer

Responsibilities:

• Create risk based PFMEA for 14 product families, evaluate HHA Hazards and manufacturing failures.
• Update master validation plan. Review IQ/OQ/PQ gaps, diplomatically and persuasively identify manufacturing process Worst Cases. Standard templates reduced clerical effort 40%.

Confidential, Dothan, AL

Senior Supplier Quality Engineer

Responsibilities:

• Resolved GD&T and CNC machining issues, completed CAPA actions 31% faster.
• Reduced new product 7000 PPM non-conformance to no defective parts in 3 months.

Confidential, Harrisburg PA

Senior Quality Engineer

Responsibilities:

• Improved DFMEA and PFMEA templates reducing the design schedule 40%.
• Implemented soldering and test method corrective actions to close customer issues within 30 days.
• Improved China facility statistical analysis, Cost of Non-Quality data led to 22% less scrap.

Confidential, Portage MI

Supplier Quality Engineer

Responsibilities:

• Reduced non-conformances 32%.
• Successful FDA recall and CAPA leading plastic part IQ/OQ/PQ re-validation with RJG Scientific Molding. Follow up to be sure the work is done correctly.

Confidential, Marysville, MI

Continuous Improvement Quality Engineer

Responsibilities:

• Reduced repeat errors 82%, Improved exterior mirror quality rating to Confidential best-in-commodity. Mentored molding and assembly departments. Reduced customer issues 54%.
• Improved profit margins 45% using Six Sigma and Toyota 5S methods. Kaizen reduced labor 8%. Saved $192,000 in 3 months, reducing the number of plastic materials 36%.
• Lean value stream mapping for molding, paint, and material handling reduced paint scrap from $9000/month to $636/month.

Confidential, Auburn Hills MI

Design Release Engineer Project Engineer

Responsibilities:

• Manage cost reduction initiatives. CHMSL lamp redesign with next generation LED’s reduced cost 21% and improved reliability. Saved $1,100,000 at an automotive fascia Tier 1 supplier.
• R&D new technology for plastic injection molding, thermoforming, extrusion, and robotic assembly. Replaced fascia paint with in mold extruded film for $20/car savings.
• Reduced exterior lighting warranty 80%. Improved headlamp beam pattern. Benchmarking and Shainin Red-X root cause analysis of Best of the Best and Worst of the Worst water intrusion.
• Positive attitude and able to do the job, build and maintain internal and external relationships. Concise communication and clear direction.

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