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Quality Engineer Tech/ Calibration Specialist

Location:
Atoka, TN
Salary:
25.00
Posted:
February 03, 2020

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Resume:

Professional Summary

Skills

Work History

DEVON ELKINS

Atoka, TN 38004 901-***-**** adblbm@r.postjobfree.com Quality Driven with over 20 years of successful experience in Quality and Medical Device. Recognized consistently for performance excellence and contributions to success in Medical Manufacturing industry. Strengths in Quality and Medical Device backed by training at all my previous and current employers. Enthusiastic and eager to contribute to team success through hard work, attention to detail and excellent organizational skills. Blueprint reading

GD&T

Inspection

Handtools and (OIS) Optical Inspection Systems

20 Years of Quality Systems

OIS programming

RMA and NMR Reviews

Device History Review (DHR)

First Articles

Internal Calibration/ Customer Gaging

Control Plans

GRR

Creation of inspection sheets

Excel ( spreadsheets creation and cond. formatting) Customer/ shipping documentation

Internal Auditing / ISO 13485 training

Quality Engineer Tech/ Calibration Tech 07/2011 to 01/2020 RMS Surgical – Memphis, TN

Inspection of medical device components .

Using inspection sheets to inspection parts to print and customer critical dimensions per customer criteria. Using various handtools such as calipers, micrometers, height gages, etc. to inspect parts per IPs. Used Comparators and micro vu to inspect parts per IPs. Creating First Articles per incoming customers purchase orders. Pulling all final documentation to be shipped with parts which would include inspection data, material and in-process certifications, CMM reports,etc. requested per customer POs and/ or customer work instructions. Creation of Inspection Sheets (IPS), using customer receiving critical criteria sheets, work instructions, QACs, IDR, IIS, etc..

When creating IPs we used conditional formatting and static information to reduce documentation errors that we shipped to the customer.

Creating of control plans that are required per each customer after the creation of IPs. The control plans mimicked the locations, inspection AQLs, etc. that are on IPs making it easier to create. MRB: Investigation of any nonconforming product found by inspectors and rejected. Investigation of RMAs ( customer returns) to verify that product actually has nonconforming dimensions/ functional issues/ visuals.

Ordering customers gages for new or re-occurring parts per customer criteria. Reviewing DHR prior to scanning them into our intenal system. In contact with customers to correct any incorrect shipping documentation or submission of deviations of product are non-conforming per print.

Internal auditing of other depts. to verify they are within conforming to their internal work instructions. Aided in other depts. at the end of the month such as assembly, passivation, metal finishing, etc. to be able to meet dates per customer POs.

Working with machinist and programmers to efficiently create Inspection sheets and control plans, Training new employees on work instructions, SOPs, etc. Education

References

Senior Quality Inspector 01/2002 to 07/2011

Odyssey Medical – Bartlett, TN

Inspected all punctal plugs that were molded per print. Inspected all plugs using pins, overlays using comparator and micro vu. Inspected parts to verify parts were within tolerance and there were no non-conforming material. Inspected molds to verify molds were still within print specifications. Aided in GRR to validate all molds used in the molding process of all of the different types of punctal plugs. Aided in the shipping dept. when needed a the end of the month so parts would be able to be shipped to sterilizer. Aided in the medical device and implants side of the business when needed. The instrument and implants using hand tools, micro vu, comparator and overlays. Aided in the creation of inspection sheets using prints and customer critical criteria. Draper and Injection Molding 01/2000 to 01/2002

Smith & Nephew (Gyrus) – Bartlett, TN

Used air operated machines to fold surgical drapes that covered microscopes, lights, etc during surgeries. Ran injection molding machines that placed handles on various medical instruments. Ran injection molding machines that molded cases that the implants were packaged in. Aided in the installation and removal of molds.

Mixed silicone in a clean room environment that was used to mold the silicone ear plug implants. Worked under the microscopes to de-flash the different styles of implantable silicone tubes, which removed all the excess material.

Inspected the silicone implants using pins and micro vu per IPs and prints. Inspected molds and sample parts to verify molds and to validate the molds during calibration dates. Aided in packaging to meet deadlines for sterilization. Graduate

Bolton High School - Arlington, TN

RMS/ Cretex University - Memphis, TN

Internal Auditing

Lean Manufacturing

Geometric Dimensioning and Tolerancing

Device History Review

Micro Vu Programming

Beth Hutchison- 901-***-**** RMS/ Verasity

Casey McDaniel- 901-***-**** RMS Surgical

Rafael Piaz- 901-***-**** RMS Surgical

Justin Bunker- 901-***-**** RMS/ Owner of Horizon



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