Medical Quality

Twila M. Manning

*** ******* **** *****

Apt *

Martinsville, IN 46151

(Cell) 425-***-****

Over 10 years of Quality Inspection & Testing experience in

Medical Device Industry

Problem solving skills

Attention to detail and accuracy

Documentation and organization skills

Experience with ISO 13485 & FDA regulations

Effective computer skills

Ability to multi-task

Experience working with calipers, micrometers, height gauges, pin gauges, microscopes, visual measuring machines

Energetic, reliable team player with strong zest and willingness to learn

Work History

Quality Assurance Technician

Greencore USA, Des Moines, WA 5/16 – 4/13/17

Trained on and performed Facility Gowning Procedures using rubber boots, lab coats, hair net and gloves. Responsibilities include verifying facility temperatures are within acceptable limits of 41degrees or lower, verifying temperature of dish room washer rinse water using a thermometer to make sure water is 160 degrees or more to ensure all bacteria is being sufficiently removed, Completing, reviewing and signing off of all documentation related to products, performing protein swabs of all allergens between production runs, verifying all weights of individual ingredients as well as completed products, verify quality of all incoming produce in Receiving Inspection is acceptable, complete DMDR if unacceptable, Monitor production lines making sure that products are being made according to SOP’s, GMP’s and customer specifications, ensure all Hygiene and Gowning Quality Regulations are being followed.

Manufacturing Support Tech II

CMC Biologics Bothell, WA 9/15-5/16

Trained on and performed Facility Gowning Procedures for Clean Room and Controlled Facilities, Preparation of cleaning and sanitizing agents including cleaning and sanitization of Clean Rooms and Controlled areas, Documented all process steps on appropriate Batch Documentation (paper and electronic), Performed Setup and Operation of Glass Wash, Autoclave Load and Unload, Collected and labeled rinse samples (TOC and Conductivity), Completed and reviewed related Documentation, Placed samples in Q.C. airlock for pickup, Delivered requested items to Manufacturing suites, Restock of airlocks and facility with supplies, Participated in department meetings, team building and training activities, Operated a large portion of working shift (12 hours) gowned in clean/aseptic area attire (scrubs, uniform, aseptic gown, hair net)

First Part Inspector

Seattle Lighthouse for the Blind, Seattle, WA 12/13-8/15

Performed First Article, In-Process, Dimensional and Final Documentation review inspections on various Aerospace machined

parts and components by reading and interpretation of Engineering blueprints/drawings and GD&T standards, Routed parts and

accompanying work orders to next operation, Logged parts into manufacturing data system, Created NCR’s when necessary, Entered job numbers and operation codes on time cards for the Blind employees and assisted them with supplies

Quality Assurance Inspector

Spiration Inc., Redmond, WA 7/13-11/13

Performed Visual, Dimensional & Documentation review inspections on machined intra-bronchial medical devices using AQL C=0 inspection criteria in an ISO 13485 regulated clean room environment, Performed Receiving inspections of purchased parts/materials, Completed all related inspection paperwork and entered SPC data into Excel spreadsheets, Completed NCR’s when necessary

Quality Control Inspector

Cook Medical, Bloomington, IN 9/03-1/13

Performed Visual, In-Process, Final & Documentation Review Inspections of various medical devices (balloon catheters, needles,

wire guides, embolization coils, sheaths and dilators, radiology devices and purchased parts) using AQL, pre-determined inspection procedures and engineering drawings, completed reject tags when necessary, routed medical devices and paperwork to Shipping Dept., Cross-trained in Incoming Q.C. where I operated/calibrated/maintained multiple Instron tensile test machines to verify strength, durability & reliability of materials, Adhered to all SOPs, CGMPs, Safety Policies/Procedures

Education

Associates Degree Sullivan College Louisville, KY

Diploma Mitchell High School Mitchell, IN

Professional References

Available Upon Request

Contact this candidate