Randall Vafias

Senior FAR *st Article OQ/PQ Process Capability Validation/Qualification Mechanical

Dimensional Inspector

Blaine, MN 55434

adxcr0@r.postjobfree.com

Summary of Professional Qualifications:

• 42 Years Experience as a Mechanical Dimensional Inspector within a Manufacturing Environment.

• Excellent Communication Skills (written and verbal) with the ability to Interact with Personnel / Peers, at all Technical and Management Levels.

• Team player who is Self-Motivated/Driven and Assertive, with very Strong Work Ethics.

• Very High Level of Dimensional Mechanical and Creative Abilities. Various Precision Inspection Gauging and Testing Equipment Experience include:

• CMM OGP Touch Probe/Vision Flash Smartscope Systems (3D Measuremind Software) Operation and some Programming experience.

• ZEISS O-Inspect CMM - Calypso Software (Operational, Existing Programs Only).

• Mitutoyo Crysta-Apex S CMM - Mitutoyo MCOSMOS Software - (Operational Existing Programs Only).

• ROI Instrumentation OMIS Vision Systems - (Operational, of Existing Programs Only).

• Micro Vu Vision Systems - (Operational, of Existing Programs Only).

• Quadra Check DRO (200, 4000 & 5000 Series)

• Optical Comparator (Mitutoyo, Starrett & Zeiss) w/Deltronic DRO.

• Deltronic & Carbide Gage Pins (.0001” increments)

• Surface Finish Profilometers (Zeiss Surfcom & Pocket Surf - Visual Roughness Comparators)

• Gauges (thread, bore, radius, plug & pin).

• Indicators (drop/dial).

• Chatillon Force & Torque Gages.

• Holix Laser Micrometer.

• Calipers (manual/digital/vernier).

• Height Stand Dimensioning.

• Toolmakers Microscope (Nikon) automated and manual.

• Micrometers (ID, OD, uni-mike multi-anvil, groove, blade, screw thread diameter, pressure, indicator/ indicating snap & depth).

• Tensile Strength Testing.

• Microscope (Bauch & Lomb).

• ID Bore Gages.

• Rockwell Hardness Testing.

• Niton XRF X-Ray Metals Analyzer.

• Digital Weight Scales (grams, ounces & pounds).

Additional Areas of Knowledge and Experience:

• Experienced with ISO 9001:2008 Aerospace AS9100 & AS9102 FAIR Requirements, Medical Devices 13485:2003 - Customer & FDA Regulatory Requirements including: GMP’s, cGMP’s (Pharmaceuticals), Material Certificates of Compliance & Analysis, (Heat Treat, Annealing, Sterilization) Processes, including Non-Conforming Materials MRB/Quarantine.

• PCB/PWB & Flex Circuits - (IPC-J-STD-001-G) - (IPC-610-C) - (IPC - WHMA-A-620-C) Soldered Electrical and Electronic PCB Assemblies, Wire Harness Assemblies and Acceptability Quality Workmanship Standards - Commercial / Military Department of Defense. Related Experience with Mechanical Dimensional Visual Inspections include:

• Preform 1st Pc. Setups / 1st Article / FAIR Receiving, In-Process and Final Inspections, including Engineering Product Development Special Work Requests, per Customer Print Specifications.

• Conduct Gage R & R Studies, OQ/PQ Process Capability Studies (Validations/Qualifications) with Full Statistics (Process Capability Analysis) including Pareto Charts and Histogram Graphs.

• Utilization of C=0 & ANSI / ASQ Z1.4 - 2008 Sampling Plans.

• Documentation Verification including Customer Print Revisions, ECO’s, ECR’s, ECA’s, Inspection Procedures (SOP’s & IP’s) and Creation of Non-Conforming Material Reports (NCMR’s).

• Assist with Gage Verifications and Equipment Calibration Requirements as needed.

• Maintain Supplied Raw Material, Heat Treat, Hardness Testing and Plating Certifications of Compliance.

• Complete Product Transfers by use of MRP/ERP Systems.

• Verification of all Incoming Raw Materials Purchased for Manufacturing, Engineering R&D Product Development & Design including: Plastic Injection Molded / Extruded Materials and Various Metals for Machining.

• Assist Engineering, Purchasing, Vendors and MRB Staff, with CAPA’s to resolve Quality Non- Conforming Issues that may arise during the Manufacturing Processes.

• Support Manufacturing Operators/Line Inspectors with correct Inspection Equipment and or Techniques/Methods, to Assure Consistent Quality Products are Manufactured to Customer Print Specifications, prior to Final Shipping.

Employment History:

Dynamic Group Inc.

13911 Unity St. NE

Ramsey, Mn 55303

NPI FAR OQ/PQ Senior Mechanical Dimensional Inspector including Process Capability Studies

(Qualifications and Validations), Product Design and Development Engineering. Nov 2021 - Currently still working here.

Spectrum Plastics Group

7309 W 27th St.

St. Louis Park, Mn 55426

OQ/PQ Process Capability Studies (Qualifications and Validations), FAR 1st Article Mechanical Dimensional Inspector (Product Design and Development Engineering). Oct 2020 to Aug 2021

Micro-Matics LLC.

8050 Ranchers Rd. NE

Fridley, MN 55432

Senior FAR /PPAP / 1st Article / 1st Pc. Setup Mechanical Dimensional Inspector May 2016 – April 2020

Integer/Lake Region/Accellent Inc.

6420 Zane Ave. N

Brooklyn Park, MN 55429

Senior Mechanical Dimensional Final Inspector/Continuous Improvement Committee June 2013 to December 2015

Aerotek Staffing/Ultra Machining Company, Monticello, Mn. 6900 Wedgwood Rd. North Maple Grove, MN. 55369

FAR, 1st Pc. Setup, Receiving/In-Process/Final Inspector September 2012 to April 2013

NASA (Goddard Space Flight Center) Greenbelt, Maryland / SQA Services Inc. Rolling Hills Estates, CA. 90275

Quality Representative/Auditor/Source Inspector/Surveillance November 2007 to April 2009

Donatelle Plastics Inc.

501 County Rd. E2 Extension, New Brighton, MN. 55112 Senior OQ/PQ Process Capability Validation/Qualification FAR 1st Article Mechanical Dimensional Inspector (Engineering R&D / Product Design & Development) November 2005 to October 2007

Boston Scientific Corp.

1 Scimed Place, Osseo, MN. 55311

Supplier Quality Assurance Receiving Mechanical Dimensional Inspector Specialist III April 2003 to July 2005

Education Anoka Vocational Technical Institute, Anoka, MN Building Equipment Maintenance Technician

1981 to1983, Graduated/Diploma

2nd Class C & 1st Class B (Low & High Pressure) Boilers Engineers Licenses. Course included: Heating, Ventilation, Air Conditioning, Low & High Pressure Boiler Systems, Electrical

& Pneumatic Controls for Machines, Energy Conservation, Concrete Technology and Water Treatment, Plumbing, Welding & Fabrication & General Machine Shop (Mills & Lathes). High School Hudson Bay High School

Vancouver, WA

1971 to 1974, Graduated/Diploma

General Courses, Including Mechanical & Architectural Drafting. SAP, Enterprise IQMS, Workflow, Minitab, QC-CALC, GageTrac, MS (Word, Excel & Outlook) and General Data Entry.

Certifications Include: SPC, GMP’s, cGMP’s (Pharmaceuticals), GD&T, CMM Touch Probe/Vision OGP Flash Smartscope.

Authorized to work in the US for any employer

Work Experience

OQ/PQ 1st Article FAR Mechanical Dimensional Inspector -Engineering Product Development and Design

Spectrum Plastics Group - Saint Louis Park, MN

October 2020 to Present

OQ/PQ Process Capability - Validation/Qualification FAR 1st Article Mechanical Dimensional Inspector / Engineering Product Development and Design Team.

Mechanical Inspections include: New Product Development prior to being approved for Production. Also Required Annual Re-Qualifications of existing Molds/Machines for Production, or that have been Reworked/Repaired.

Also perform GR&R’s and Process Capabilities Qualification/Validations, which includes Full Statistics with Pareto/Histogram Charts.

Senior FAR 1st Article/1st Pc Setup Mechanical Dimensional Inspector Micro-Matics LLC - Fridley, MN

May 2016 to April 2020

Quality Assurance FAR / 1st Article / 1st Pc. Setup / In-Process / Final Mechanical Dimensional Inspections of Precision Machined Component Parts, prior to Outsourcing (i.e. Heat Treat, Hardness Testing, Plating, Special Processes, etc.) or Final Shipment Deliveries. Senior Mechanical Dimensional Final Inspector

Integer/Lake Region Inc. - Brooklyn Park, MN

June 2013 to December 2015

Final Mechanical Dimensional & Visual Inspections of Precision Machined Medical Device Components, prior to Customer Deliveries.

1st Pc. Setup / 1st Article / FAIR / Receiving / Final Inspector Ultra Machining Company / Aerotek Staffing - Monticello, MN September 2011 to April 2012

1. 1st Pc. Setup / 1st Article / Receiving / Final Mechanical Dimensional & Visual Inspections of Incoming Raw Materials and Precision Machined Medical Device Components, prior to Customer Deliveries. NASA Quality Assurance Source Inspector Representative - Surveillance/ Witness/Documentation Auditor

NASA (Goddard Space Flight Center) / Remmele Engineering - Big Lake, MN November 2007 to April 2009

Source Inspection of International Space Station (Express Logistics Carrier) Deck Structure, during the entire Manufacturing and Build Operation Requirements per NASA (Goddard Space Flight Center) which included:

1. Visual Inspections and Verification/Witness of all 1st Pc. Setup / 1st Article, In-Process and Final Inspections & Records & Reports were within NASA Print Specifications during the entire Machining Manufacturing Process.

2. Witness / Observe / Verify Daily Assembly Build Operations were followed, per NASA (GSFC) Assembly Requirement Instructions and Customer Purchase Order Agreement. 3. Verification of Correct Space Flight Hardware used during Assembly and Hardware Torque Value Requirements were correct and logged per NASA - ICD Print Specifications. 4. Documentation Auditing to Verify Completeness & Accuracy (including all Non-Conforming Reports were completed and closed out).

5. Verification of all Inspection Gage Equipment Calibration Records used during Manufacturing were Current.

6. Correct Vendor Plating Certifications Verification. 7. Serialized Ink Stamp Part Marking Verification (all Assembled Components) logged and recorded. 8. Material Certificate of Analysis & Certifications of Compliance Verification's. 9. Verification of all Chemical Conversion Touch-up Coating during Assembly Operations Holes per NASA GSPC Specifications.

10. Witness/Verification of Final Product Cleaning Processes, Critical Lifts & Packaging Requirements prior to Product Delivery.

OQ/PQ 1st Article FAR Mechanical Dimensional Inspector - Engineering Product Design and Development

Donatelle Plastics Inc - New Brighton, MN

November 2005 to October 2007

Senior 1st Article OQ/PQ FAR Mechanical Dimensional Inspector (Engineering Design & Development), including: Gage R & R, Process Capability and Characterization Studies, with Full Statistics. Senior Receiving Supplier Quality Assurance Mechanical Dimensional Inspector Specialist III

Boston Scientific Corp. - Maple Grove, MN

April 2003 to July 2005

1. Mechanical Dimensional Inspections of Received Medical Device Components from Contract Manufacturing Suppliers & Raw Materials including Chemicals/Pharmaceuticals, prior to In-house Manufacturing and Final Assembly Operations.

2. Mechanical Dimensional Inspections of Special Work Requests (as needed) for Engineering Product Design & Development.

Education

Diploma in Building Equipment Maintenance Technician (HVAC & Low /High Pressure Boilers

Anoka Vocational Technical Institute - Anoka, MN

September 1981 to June 1983

Diploma - Architectural / Mechanical Drafting in Architectural / Mechanical Drafting

Hudson Bay High School - Vancouver, WA

1971 to 1974

Skills

• Calipers

• AS9100

• Coordinate Measuring Machine

• Dimensional Inspection

• ISO 9001

• Manufacturing

• Micrometer

• Quality Inspection

• Word, Excel, Outlook and General Data Entry

• IPC 610

• GD&T

• Quality Assurance

• Internal Audits

• PPAP

• 5S

• Plastics Injection Molding

• ERP Systems

• Quality Control

• SAP

Certifications and Licenses

Statistical Process Control Certification

May 1987 to Present

Statistical Process Control Certification (On-Site Employer Required Training). GMP Training Certification

November 2004 to Present

Good Manufacturing Practices Certification (On-Site Employer Required Training) cGMP Certification (Pharmaceuticals)

November 2004 to Present

cGMP (Pharmaceuticals) Training Certification (On-Site Employer Required Training) GD&T Training Certification

September 2007 to Present

Geometric Dimensioning and Tolerancing Training Certification. (On-Site Employer Required Training). OGP Flash Smartscope Vision System (3D Measuremind Software) Operational Training Certification

December 2016 to Present

CMM / Vision System - OGP Flash Smartscope (3D Measuremind Software) Operational Training Certification. (Not Employer Required)

Assessments

Manufacturing: Quality Inspection — Highly Proficient April 2020

Making precise measurements, reading prints, and making pass/fail decisions. Full results: Highly Proficient

Work Style: Reliability — Highly Proficient

September 2020

Measures a candidate's tendency to be dependable and come to work. Full results: Highly Proficient

Work style: Reliability — Highly Proficient

September 2020

Tendency to be dependable and come to work

Full results: Highly Proficient

Manufacturing: Quality inspection — Highly Proficient April 2020

Making precise measurements, reading prints, and making pass/fail decisions. Full results: Highly Proficient

Attention to detail — Completed

June 2020

Identifying differences in materials, following instructions, and detecting details among distracting information.

Full results: Completed

Attention to detail — Familiar

September 2021

Identifying differences in materials, following instructions, and detecting details among distracting information

Full results: Familiar

Indeed Assessments provides skills tests that are not indicative of a license or certification, or continued development in any professional field.

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