QA Engineer

Atalys, LLC•Asheboro, NC

12d•$80,000 - $90,000•Onsite

About The Position

This is a dual role that provides support to sustaining manufacturing by applying quality engineering principles to manufacturing’s continuous improvement efforts, and support, direction and training for Quality Control functions and personnel.

Requirements

Experience in medical or pharma manufacturing
Strong analytical skills
Knowledge of Project Management concepts and skills
Desire for achieving excellence in customer satisfaction, process and product quality
Strong detail-oriented written and verbal communication skills, including customer interactions
Strong knowledge of and practical experience using problem solving & root cause analysis tools (e.g., 8D, 5-Why, fishbone, etc.)
Knowledge in measurement systems analysis (MSA/GR&R)
Proficient in Geometric Dimensioning & Tolerancing GD&T ASME Y 14.5
Working knowledge of ISO-13485 and FDA cGMP
Application of time management tools
Knowledge of industry statistics including use of Minitab or similar statistics analysis software
Prior supervisory experience preferred
Experience in Plastic Injection Molding preferred
Ability to positively motivate others
Must be self-motivated
Minimum of a four-year Engineering / Technical Degree or equivalent experience (i.e., 3 to 5 years)
Minimum of five years (3) of experience in a similar role

Nice To Haves

ASQ certification is a plus

Responsibilities

Will work independently and in a team environment to support the daily function of the sustaining manufacturing operation
Investigate customer complaints and develop corrective action that mitigate the existing risk.
Problem solving using formal CAPA tools.
Manages the planning and execution of quality assurance strategies as well as product testing efforts.
Develops and implements standards and methods for inspection, testing and evaluation of materials, products and processes.
Develops sampling procedures, designs and develops forms and instructions for recording, evaluating and reporting quality data.
Works from drawings, specifications, and inspection quality control instructions using an assortment measuring tools, fixtures and equipment such as micrometers, Vernier’s, gauge pins, height gauges, comparators, gear checkers, etc.
Supports the performance of visual and dimensional checks receiving inspection, in-process or finished products.
Notifies Production personnel of deviations and works towards rectification of defects and identification and control nonconforming products
Supervises Quality Inspectors and sorting personnel, on all shifts, to ensure that team members are meeting goals, as well as, working with Production team in meeting quality goals
Simultaneously fulfil responsibilities on multiple projects and activities
This job description indicates the general nature and level of work, duties and responsibilities expected of the incumbent.
The incumbent may be asked to perform other duties as required.
The job description may be changed if needed as determined by the Company.