Atoka, TN 38004 901-***-**** firstname.lastname@example.org 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
Handtools and (OIS) Optical Inspection Systems
20 Years of Quality Systems
RMA and NMR Reviews
Device History Review (DHR)
Internal Calibration/ Customer Gaging
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
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
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