William Langen
Duluth,MN
Summary
Quality & Regulatory Manufacturing Engineering Professional with a successful career record in promoting and implementing quality management systems within Medical Device and Aerospace Industries. Skilled in working with project quality teams, supplier quality and manufacturing quality control staff to produce best-in-industry, highly regulated products.
Overview
37
37
years of professional experience
5
5
Certification
Work History
Principal Quality / Regulatory Engineer (Consultant)
DJO Global
2022.01 - 2023.03
- Served as Quality Engineering SME (CAPA, RCA, Validations, Supplier Quality etc) on EU MDR Team
- Write Risk Management Part 5 for EU MDR Files for Surgical Systems, Knee, Shoulder, Ankle, Fingers & Etc
- Managing and reviewing all Design Changes, CAPAs, Quality Agreements, PFMECA, DFMEA, Validations, IQ, OQ, PQ, Risk Analysis, Supplier Data and MDT data and etc
- Managed and Lead Corporate Wide Effort to Assure Suppliers Conformed to EU MDR Standards.
- Used critical thinking to break down problems, evaluate solutions and make decisions
- Demonstrated strong organizational and time management skills while managing multiple projects
Principal Quality Engineer (Consultant)
Medtronic / Cardio Vascular Group CVG
2019.07 - 2022.02
- Served as Quality Engineer SME (Subject Matter Expert) on EU MDR Remediation Team of 21
- Work with Contract and OEM Suppliers to Conform to EU MDR Standards
- Investigate Gaps and Remediate - Red Line Labels for NPI and Legacy Med Products
- Developing Process and Validation Workflows
- Team member reviewing all CVG EU MDR Design Changes, CAPAs, Quality Agreements, PFMECA, DFMEA, MVP, IQ, OQ, PQ, Risk Analysis, Supplier Data and MDT data and etc
- Used Solid Works, Enovia, JDE, Oracle and Agile on a daily basis to manage Document changes, study specifications and etc
- Trained Team on RCCA Tools / Ishikawa Methods – 5 Whys, Cause Effect, Fault Tree…
- Obtained 178 Cornerstone Training Certificates in ISO13485, Purchasing, Quality, SAP, Change Control, Supplier Controls, CAPA, QMS, HIPAA, Supplier Management and Etc......
- Effectively Interact daily with Design Engineering, Legal, Regulatory Affairs, Packaging Engineering, Manufacturing, Suppliers and etc..
- Contributed to root cause analysis to determine core reason for failures and errors.
- Coordinated with quality control staff to complete inspections.
Sr. Corporate Supplier Quality Engineer (Consultant)
3M Corporation
2018.02 - 2019.06
- Medical Surgical Division
- Write / Provide Corporate Level Supplier Quality Training / Support to 60 Global Manufacturing Facilities
- Train Global Suppliers and 3M Locations On CAPA, Validation, SPC, Inspection Reduction etc.
- Standardize Supplier Quality Processes within 3M Medical Surgical Divisions
- Provide advice to Manufacturing Facilities, Oral Care, Surgical, Infection Prevention & Pharma Divisions
- 3M Auditor, ISO 13485 Auditor – Quality Engineering SME for 3M Global Surgical
- Analyzed issues with supplier contributions to detect defect trends, reporting findings to appropriate personnel.
- Designed inspection plans and methods for execution by personnel at remote locations, verifying accurate implementation and data collection.
Sr. Quality Engineer /Consultant
Lockheed Martin, Aeronautics
2016.08 - 2017.02
- Oversee all Manufacturing Quality of Air/Air Re-fueling Systems Lockheed Martin C130 AC
- Work Under AS9100, Air Force, Marines and other Governmental Requirements
- Contributed to root cause analysis to determine core reason for failures and errors.
- Performed quality inspections and drafted reports to detail non-conforming material issues.
Senior Specialist Quality Engineer / Manager
Cirrus Aircraft
2012.01 - 2016.08
- Successfully Manage all Aspects of Quality / TC and PC Conformity for the SF50 Cirrus Vision Jet Development / PC FAA Certification
- Successfully Implemented and Managed the Oversight of >300 suppliers
- Audits, Surveys, SCARs…
- Performed and Trained Cirrus, Managers, Suppliers, Engineers,Techs and Inspectors in All Aspects of Inspection, SPC, Cpk, LEAN / 6S, Ishikawa, CAPA, RCCA and how to Measure Processes
- Taught Cirrus Management, Engineers on How to Measure Process’s to Reduce Inspections and Increase Quality Using Lean / 6s and Statistics
- Develop / Improve Suppliers (Avionics, GPS, Interiors, Engines, De-Ice, Oxygen Etc..)
- Investigate Internal and Field Failures – Implement and Mange and MRB (Material Review Board) To Determine Dispositions
- Develop and Manage a Supplier Quality Scorecard Program
- Implement and Managed an MRB System / Team
- Contributed to root cause analysis to determine core reason for failures and errors.
- Manage 5 Engineers and 8 Technicians
- Develop and Manage a QMS Based on the AS9100 Standard
Sr. Quality Engineering Manager
Rockwell Collins Aerospace, Aircraft Interiors
2006.01 - 2012.01
- Work in Cross Functional Cost Down Teams with B/E Nogales Mexico and Outside Suppliers
- Measure and Drive Improvements of Many Types of Processes, Molding, Assembly Etc…
- Measure, Communicate and Improve Suppliers
- Implemented PPAP and Supplied Data Program with Suppliers, Including Packaging Performance and Testing
- Implement SPC, Sampling Plans and Inspection Procedures
- Contributed to root cause analysis to determine core reason for failures and errors.
- Performed quality inspections and drafted reports to detail non-conforming material issues.
- Manage all Quality Aspects of 56 Million per Year Project
- Manage MRB, attend Production / Project / ECB / IPT and Design Meetings Daily
- Improve Quality of Many Diverse Departments Model Shop, Paint, Upholstery and Electrical
- Supervise, Manage and Train Inspection Personnel, Engineers and Technicians
- Supervise Calibration, Test Engineers / Technicians and Inspection Personnel
- Plant Administrator for HQMS (Harrington Quality Management System)
- Process Validations, IQ, OQ, PQ, Gauge Studies
- Quality SME on New Product Introduction Teams
- Train LEAN and 6 Sigma Concepts / Scrap Reduction
- Determine Criticality (FMEA) and Write Inspection Procedures Accordingly
- Set Up Successful Supplier Quality Assurance Program
- Manage 6 Engineers and 13 Technicians
Quality Engineer
Ametek / TSE Inc, Bio Medical Electro Mechanical Devices
2002.01 - 2006.01
- Designed, Simplified, Implemented and managed many "Money Saving" Systems for TSE
- Designed, Implemented and Oversee "Measurable" Supplier Quality Assurance Program
- Worked with Suppliers to Improve Quality, On Time Delivery and Cost Down Efforts
- Managed ISO Internal Conformance Auditors, Schedules and etc.
- Train Employees on SPC, LEAN, FMEA, DOE, Fault Tree, 5 Whys and Other Problem Solving Tools
- Write Validation Protocols and Conduct IQ, OQ, PQ Validations
- Managed all Aspects of TSE Supplier Quality Efforts
- Quality Representative with Design Teams
- Coordinated with quality control staff to complete inspections.
- Contributed to root cause analysis to determine core reason for failures and errors.
Supplier Quality Engineer
Boston Scientific Corporation
1995.01 - 2002.01
- Train Suppliers on CAPA, RCA
- Reporting Supplier Quality Improvement Efforts to Management
- Write and Edit Inspection Procedures
- Write Validation Protocols and Conduct IQ, OQ, PQ Validations
- Analyze Field Failures, CAPAs, Conduct RCA and Follow ups
- Performed Reliability and Capability tests to help gain Regulatory approval
- Work with External Suppliers and Customers on Quality Issues
- Supervised Supplier Quality Inspectors, Technicians and Engineers
- Train Technicians/Engineers on Measurement Techniques & Statistical acceptance criteria
- Perform calibrations
- Write calibration procedures
- Measure, Communicate / Improve Suppliers
- Implemented Supplied Data Program with Suppliers
- Worked within 13485, FDA and ISO Regulations
- Analyzed issues with supplier contributions to detect defect trends, reporting findings to appropriate personnel.
- Designed inspection plans and methods for execution by personnel at remote locations, verifying accurate implementation and data collection.
Test Engineer, Manufacturing Engineer, Operations Manager
3M Medical Surgical Division
1986.01 - 1995.01
- (Visual Systems, Security Systems & Medical Surgical Divisions)
- Served on ISO 9000 Teams, Trained Company and Departments on ISO Standards
- Certified 3M Internal Conformance Auditor ISO9000, UL, CSA, FDA Standards
- As Test Engineer, I wrote and performed reliability tasks and reported results
- As Operations Manager I Managed Production of over 15 different types of Surgical Staplers and LAD’s
- Supervised and Managed 48 Production Employees in Clean room manufacturing settings
- Managed Supervisors work flow and all aspects of Medical Device Manufacture.
- Applied project management metrics and tools in oversight of engineering and manufacturing projects and program services.
Education
Bachelor of Science degree - Engineering Technology
Temple University
Philadelphia, PALean / 6 Sigma Blackbelt
Villanova University
Villanova, PASkills
- Regulatory Compliance Assurance
- Maintaining Quality Assurance Standards
- Supplier Quality
- Train Staff
- Developing Quality Standards
- Quality improvement prioritization
- Quality Management Systems
- Quality analyses
Certification
- Certified Villanova LEAN / 6 Sigma Black Belt 2016
- Certified ISO13485:2016 Lead Auditor 2023
- Certified ISO13485:2016 Internal Auditor 2018
- IPC-620 (Wire Harnesses) Certified Instructor 2015
- Toyota / University of Kentucky LEAN Management Program / Certificate 2009
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Timeline
Principal Quality / Regulatory Engineer (Consultant)
DJO Global
2022.01 - 2023.03
Principal Quality Engineer (Consultant)
Medtronic / Cardio Vascular Group CVG
2019.07 - 2022.02
Sr. Corporate Supplier Quality Engineer (Consultant)
3M Corporation
2018.02 - 2019.06
Sr. Quality Engineer /Consultant
Lockheed Martin, Aeronautics
2016.08 - 2017.02
Senior Specialist Quality Engineer / Manager
Cirrus Aircraft
2012.01 - 2016.08
Sr. Quality Engineering Manager
Rockwell Collins Aerospace, Aircraft Interiors
2006.01 - 2012.01
Quality Engineer
Ametek / TSE Inc, Bio Medical Electro Mechanical Devices
2002.01 - 2006.01
Supplier Quality Engineer
Boston Scientific Corporation
1995.01 - 2002.01
Test Engineer, Manufacturing Engineer, Operations Manager
3M Medical Surgical Division
1986.01 - 1995.01
Bachelor of Science degree - Engineering Technology
Temple University
Lean / 6 Sigma Blackbelt
Villanova University
- Certified Villanova LEAN / 6 Sigma Black Belt 2016
- Certified ISO13485:2016 Lead Auditor 2023
- Certified ISO13485:2016 Internal Auditor 2018
- IPC-620 (Wire Harnesses) Certified Instructor 2015
- Toyota / University of Kentucky LEAN Management Program / Certificate 2009