QA Engineer

Position Summary

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.

Essential Duties and 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.

Required Competencies, Skills and Experience

• 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

Education and Job Experience Requirements

• 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
• ASQ certification is a plus

Work Environment and Physical Demands

• Regularly required to sit and use hands
• Occasionally need to lift and/or move up to 10 pounds, with a potential of up to 25 pounds.
• Physical hazards from moving equipment and machine parts
• Sedentary, office environment; frequent exposure to manufacturing plant floor requiring the use of personal protective equipment (e.g., ear plugs, safety glasses, etc.) and following good manufacturing practices.

*The work environment and physical demands detailed above are representative of those encountered while performing the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the job.*

Disclaimer

The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time as needed.