Customer Service Quality Control
Resume:
Brian Alger
Mobile: 978-***-**** ********@*****.***
SUMMARY: Quality Control, Supplier Quality Engineering, and Vendor & Customer Relations
MARKET SECTOR: Medical Device/Pharma Industries
Contracted at: Thermofisher/Dionex/ESA, Insulet, Abiomed, Transmedics, Inc., Corindus Inc.
MARKET SECTORS: Medical, Aerospace, Defense and Contract Mfg. Industries (ISO9001)
APPLICATIONS: VH22 Osprey, Space Shuttle, and G.E. Turbine Engines
MATERIALS: Plastic, metal, PCB boards, sub-assemblies, piece parts, fibers & chemicals
EQUIPMENT: Proficient with geometric dimensioning & tolerance, surface plate set-ups, micrometers, height gages, Vernier’s, dial indicators, lab equipment, Oscilloscopes, Digital Volt Multimeters, Logic Analyzers. Advanced knowledge of equipment used daily on incoming Medical Grade small piece parts.
KNOWLEDGE: QC/Production Supervisor/Lead (ISO13485) (ISO9000-1)
First Article, In-Process & Final Inspection, Mechanical/Electrical
FDA Regulations, cGMP/SOP practices, ORACLE, SAP, ECO’s, MRB, OSHA/Safety, Hazmat training and chemical receiving/labeling/storage
Calibration of all equipment in inspection department
Fabrication of materials and prototypes
Tolerancing to ASME Y14.5 (GDT)
Test/repair returns, and maintain defect RMA tracking Db utilizing Teledyne QUIKLOOK Testing Software
R&D Prototype Design - Quality Manufacturing/Engineering support
Blueprints, schematics, assemblies, soldering, cable/harness
SKILLSET/RESPONSIBILITIES:
● Support regulatory and agency inspections, audits, investigations, and inquiries regarding the control assessment of
product design and manufacturing quality. Familiarity with BOM. Support and on-site customer source inspections.
● Involvement in the entire business cycle including: supporting of sales, customer specification reviews, procurement
activities: including supplier communication, conducting final design reviews, and ongoing support through shipment.
Preparation of inspection prints, supporting engineering calculations, quality control/testing.
● Direct liaison for any mechanical quality notification activity and data related concerns to customer; Select methods and
tools to support inspection and productions groups and monitor revisions.
● Communicating with suppliers on quality issues during both supplier maintenance/selection process.
● Performing supplier audits, sourcing/evaluating vendors, establishing vendor rating systems, developing
procurement contracts, and responsible for reliability of raw materials.
● Monitor Lead MRB Disposition meetings, Lead generation and completion of protocols.
● First Article, In-process, and Final Inspection reports and performed route cause analysis/generated corrective action.
● Performing functional & acceptance test procedures, return acceptance procedures and quality testing on: assemblies,
subassemblies, modules, wiring assemblies, and document trends/findings.
EXPERIENCE: 4/21-8/2023 Desktop Metal (3D Printing) QUALITY SPECIALIST
Set up new QC Metrology Lab. Took over handling maintenance of nonconforming database. Helped position Quality Dept. resources to improve output and accuracy in all areas. Suggested best software for CMM to Executive Management. Set up additional equipment as needed. Worked with Build Techs to resolve/expedite quality issues. Interacted with other engineers to resolve ECO updates/escalating issues. Performed inspection of critical parts; Contributed to the development of
our MRB process.
3/2018 to 2/2020 Teradyne (Contract 2 yr.) QUALITY ENGINEER– GSO
Directed daily operational activities of a team in Costa Rica. Worked with Engineering in all countries to resolve discrepancy issues (i.e., photographed & cataloged circuitry on all pc boards, worked with mechanical lab, worked with final config build before shipping to customer, and worked with shipping and receiving to meet customer due dates.) Coupled with, resolving CAPAs & DMRS via working closely with vendors. Traveled to Costa Rica and to other vendors throughout the US.Inspect PC Boards to IPC -610- STD.
2016 to 2018 Pencom Salem, NH (November to January) (My permanent position was relocated to CA)
QUALITY ENGINEERING TECHNICIAN REPORTING TO PRESIDENT -Key Account Quality support to Baxter Medical Device for Pencom supply product. Assured outgoing product for assignment parts/customers meets all contractual agreement in a manner that supports cost effective on-time product deliveries and process. Supported generation/verification of quality reports, on-site customer source systems, revisions, RMA and MRB.
2015-2016 MT Unirepair Wilmington, MA (Oct – Nov) (contract) QUALITY SPECIALIST
Received mechanical and electrical customer failed parts. Entered them into repair database and researched root cause of failures. Also, maintained tool calibration Db. Performed: In-process Inspection of electrical/mechanical assemblies and Electrical Testing of RMA’s.
2015 Four Star – Hudson, MA June – September (contract ended) QUALITY SUPERVISOR REPORTED TO PRESIDENT
Supervised 10-12 floor technicians/assemblers/wire harness workers in daily activities (i.e. training, problem resolution pertaining to Quality issues and maintaining on-time customer shipments). Technical resource to President-Suppliers.
2014-2015 Corindus Medical Device – Waltham, MA (contract ended) QUALITY TECHNICIAN (November – March)
Performed volume mechanical/electrical inspection on medical devices, assemblies and piece parts.
2013-2014 Weirs Valves – Ipswich, MA (Employee) August – February ENGINEERING BUILD/TEST TECHNICIAN
Handled building/testing of nuclear valves, electric, pneumatic, mechanical and prototype applications. Completed entries into Teradyne Quick Look Software. Analyzed and reported data to Production Engineers.
2012-2013 Atronix, Billerica, MA (Employee) October – July SUPERVISOR OF QC & ASSEMBLY DEPT&VENDOR QUALITY REPORTED TO PRESIDENT (closed plant) Supervised 8-10 people (assemblers/harness). Assisted President in resolving vendor source/quality issues. Inspect to IPC -620 STD.
2012 Analogic Corporation – Peabody, MA (contract) March – September SR. MECHANICAL/ELECTRICAL INSPECTOR
Worked closely with Engineers on ECO updates and resolved quality issues related to CAT scan, MRI, Ultrasound and airport security scanners. Analyzed inspection techniques, records, reports, procedures, and suggested the most appropriate way to inspect parts. Handled/participated in ISO 9001 audits.
EDUCATION:
Associate Degree in science-Middlesex Community College – Bedford & Lowell, MA
IT Support Technician Certificate (1yr. program)
REFERENCES: Excellent professional written references will be furnished upon request.
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