Dan Woda

Dan Woda Email and Phone Number

Senior Quality Engineer at Argon Medical @ Argon Medical
frisco, texas, united states
Dan Woda's Location
Athens, Texas, United States, United States
Dan Woda's Contact Details

Dan Woda personal email

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About Dan Woda

30 years of work experience and education to the MS level with multiple professional society certifications. Goal - medical device leadership for improvements in the quality management system, implement actions to ensure safe and effective medical devices are designed & manufactured so as to ensure regulatory compliance and company objectives.Specialties: Quality Assurance/Control & Project Management system design and implementation. Strong abilities and understanding of ISO 13485 & 21 CFR part 820. Well experienced across many Quality disciplines.

Dan Woda's Current Company Details
Argon Medical

Argon Medical

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Senior Quality Engineer at Argon Medical
frisco, texas, united states
Website:
argonmedical.com
Employees:
412
Dan Woda Work Experience Details
  • Argon Medical
    Senior Quality Engineer
    Argon Medical Jan 2015 - Present
    Athens, Texas
    QA Engineering tasks related to Risk Management, Design Controls, CAPAs, etc.
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  • Inova Labs
    Senior Quality Engineer
    Inova Labs Jan 2013 - Oct 2014
    Austin, Texas Area
    Medical device, portable oxygen concentrators, electronics, software, design controls, CAPAs, all the standard quality management system topics.
  • Djo Surgical In
    Quality Assurance Engineer
    Djo Surgical In Oct 2007 - Dec 2012
    Medical device industry: Orthopedic implant and instrument manufacturing.Initiated numerous changes/improvements to QMS for improvements in effectiveness and efficiency.Served as QE for New Product Introduction project assignments using Design Controls per CFR 21 part 820 and ISO 13485.Performed Material Review Board activities, issued SCARS/CAPAs.Planned for and performed supplier QMS audits and internal QMS audits.Processed Product Complaints, MDR determination, performed investigations for complaints.
  • Stryker Orthopedics In
    Project Manager/Quality Engineer
    Stryker Orthopedics In Aug 2005 - Jul 2007
    Medical device industry: Orthopedic implant and instrument manufacturing.Projects: instrument redeployment, returned product, NCRs, CAPAs, decontamination line, procedure changes, environmental measuring instruments, receiving/shipping, inventory verification.Documented Capital Expenditure Requests, analyzed costs, ROI and payback period.Developed and executed validation plans for new equipment, purchased new equipment. Performed internal audits (5-S) based on "lean" methodologies.Worked in FDA regulated organization, ISO 13485, CFR 21 part 820 QMS.
  • Charles Schwab & Company, Inc
    Senior Staff
    Charles Schwab & Company, Inc Mar 2003 - Sep 2004
    Financial industry: investments, trading, various financial tools.IT projects: Help-Desk redesign, work task data base changes, departmental performance metrics, technology mergers, policy & procedures, operated with significant autonomy under VP direction.Managed cross-functional technology teams to achieve project goals & objectives.Used quality improvement tools and technologies to make changes to improve service levels of the Technology Services group for internal technology users; cycle time reductions, effectiveness.Worked in SEC regulated organization, COBIT capability maturity model, IT, Financial Industry
  • Tech Group, Inc
    Development Quality Engineer / Project Engineer
    Tech Group, Inc Feb 1998 - Mar 2003
    Medical device industry: component manufacturing.New product introductions, plastic injection molding, employed at Customer/Engineering center.Worked on and/or led project teams to realize new business opportunities and transfer to production.Utilized design reviews, process development, product assurance, process verification/validation tools.Used MS Project, MiniTab, Word, Excel, SPC, DOE, capability studies, GR&R, GDT, ANOVA, t-test, f-test, PFMEA, design reviews, control plans, auditing, inspection, CAPA, Project Definition Documents, ROI, payback period, quoting, scheduling tools, critical path, and numerous other quality & project tools.Customers worked with
  • Woda Brush & Roll, Inc
    President
    Woda Brush & Roll, Inc Aug 1994 - Jan 1998
    residential and commercial licenses, entrepreneurial start-up.Entrepreneurial start-up; residential and commercial painting contractor. Closed-down debt free.I ran my own company - terrific experience. Only 2 customer complaints! Prevention was the key.Steady growth realized through lots of hard work, planning, execution, and customer satisfaction.
  • Trw Automotive Safety Systems
    Process Quality Engineer
    Trw Automotive Safety Systems Oct 1993 - Sep 1994
    Laser welding, ultrasonic welding, electronic subassemblies for automotive air-bag devices.Ensured product quality in sub-assemblies and inflators, dynamic materials/electrical, ballistics.One of my self initiated projects saved $1.5M annually.
  • Ganton Technologies, Inc
    Senior Quality Engineer
    Ganton Technologies, Inc Sep 1991 - Oct 1993
    Automotive: aluminum dies casting & machining.CPk/CP, ANOVA, DOE, SPC, PFMEA, GDT, CAPA, control plans, ISO-9001 QMS, PPAP.Worked with New Product Introductions, daily MRB, internal auditing, various QE tasks.
  • Ji Case In
    Quality Engineer / Supervisor
    Ji Case In Aug 1989 - Sep 1991
    Heavy/Construction equipment component metal casting.Supervised 8 UAW members in a sand testing laboratory for a foundry, mostly engine blocks.Customer contact for over 50% of our business regarding all quality related actions, CARs.CPk/CP, ANOVA, DOE, SPC, PFMEA, GDT, CAPA, control plans, supplier quality, training.
  • Navistar International
    Quality Engineer
    Navistar International Jun 1988 - Aug 1989
    Large transportation vehicle component metal casting.Operated metallurgical testing equipment, tested materials, kept data & records, SPC, reports.Designed and developed the plant quality manual for the quality management system.CPk/CP, ANOVA, DOE, SPC, PFMEA, GDT, CAPA, control plans, metallurgical reports.This was a first position out of college, left for more money at JI Case.

Dan Woda Skills

Quality System Capa Iso 13485 Medical Devices Fda Spc Quality Assurance Manufacturing Design Control Validation Design Of Experiments Supplier Quality Process Improvement Cross Functional Team Leadership

Dan Woda Education Details

Frequently Asked Questions about Dan Woda

What company does Dan Woda work for?

Dan Woda works for Argon Medical

What is Dan Woda's role at the current company?

Dan Woda's current role is Senior Quality Engineer at Argon Medical.

What is Dan Woda's email address?

Dan Woda's email address is da****@****ing.com

What schools did Dan Woda attend?

Dan Woda attended Keller Graduate School Of Management Of Devry University, University Of Wisconsin-Stout.

What skills is Dan Woda known for?

Dan Woda has skills like Quality System, Capa, Iso 13485, Medical Devices, Fda, Spc, Quality Assurance, Manufacturing, Design Control, Validation, Design Of Experiments, Supplier Quality.

Who are Dan Woda's colleagues?

Dan Woda's colleagues are Cheryl Kuster, Lani Bergantin, Mary Mary, Randall Willis, Fred Mayhall, Robert Martin, Ling Yu.

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