Quality Assurance Engineer

Posting Date: 12.23.2019

Job Title:  Quality Assurance Engineer Status:  Salaried, Exempt
Department:  Quality Reports to:  Director of Quality

Job Summary:

The Quality Engineer acts as a key customer contact for all quality related issues within operations. They work collaboratively with the Certified Floor Auditor Level IIIs and the Quality Layout Technicians as well as members of the Production and Customer Service teams to ensure that all quality standards are being met. They formulate operating practices to address preventative action requirements in order to avoid non-conformance and ensure that end products meet and/or exceed customer specifications.

Duties and Responsibilities:

  %  Time Essential/ Non Essential
1. Leads continuous improvement efforts within the manufacturing cell. Analyzes data to determine appropriate Root cause and corrective actions needed. 30 E
2. Responsible for review and disposition of non-conforming product. 5 N
3. Develops qualification protocols and control plans to meet all customer requirements while minimizing scrap and eliminating customer returns. 30 E
4. Verifies that all appropriate instructions are in place to meet customer, FDA and/or other outside agencies requirements. 15 E
5. Supports CFA Level III and Quality Layout Technicians by creating and explaining procedures and quality standards. 20 E
  The above statements are intended to describe the principal functions of the position.  They are not intended to encompass all duties. There may be additional duties assigned by your supervisor based on business needs.

Qualifications:

MINIMUM QUALIFICATIONS

  1. Degree in relevant field of study and 2+ years experience in quality engineering or A High School Diploma, GED and a minimum 5+ years manufacturing experience.
  2. Ability to work with minimal supervision.
  3. Possess an attention for detail with a high degree of accuracy.
  4. Advanced computer experience/ proficiency.
  5. Ability to read and interpret documents such as safety rules, blue prints, operating and maintenance instructions, and SOP’s.
  6. Ability to add, subtract, multiply, and divide, using whole numbers, common fractions, and decimals.
  7. Must apply common sense understanding to carry out instructions furnished in written, oral, or diagram form.
  8. Ability to multitask and problem solve involving several variables in working situations.
  9. Proficient in use of statistical tools and have a strong understanding of Statistical Process Control methodology to the quality assurance process.

PREFERRED QUALIFICATIONS:

  1. BS/BA degree in relevant field of study
  2. Six-sigma experience green or black belt.
 

Competencies:

Individuals should possess the following competencies to perform the job successfully. Individuals should possess the following competencies to perform the job successfully.
  1. Communicates effectively, in oral and written communications. Translates company procedures and technical data into information that internal or external customers will understand.
  2. Implements and manages change by clarifying new processes and continuously providing communication to support change. Recognizes areas for improvement and takes actions to implement those improvements.
  3. Solves problems effectively by considering alternative solutions and possible consequences and takes into account other perspectives before making decisions.
  4. Attention to detail with thoroughness in accomplishing tasks. Monitors and checks work, plans and organizes time and resources efficiently.
  5. Builds strong relationships, works effectively and relates well with others including coworkers and those outside the organization. The employee exhibits a professional manner in dealing with others and works to maintain constructive working relationships.

Working Conditions:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. The employee is frequently exposed to work near moving mechanical parts, vibration and an environment with moderate noise levels.  May be required to work in a controlled environment requiring special garb (ex. coats, hairnets, and facial hair guards), gloves and prohibiting specific items.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.
  • The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds.
  • Specific vision abilities required by this job include: close vision, distance vision, peripheral vision and ability to adjust focus.  Must possess sight and hearing senses or by the use of prosthetics that enable these senses to function adequately.
  • Employee is regularly required to sit, talk and hear, to use both hands to finger, handle, or feel; and reach with hands and arms.  The employee is frequently required to stand and walk.  The employee is occasionally required to stoop, kneel, or crouch, and climb or balance.
  • The employee must be able to adhere to all safety procedures and practices.
  • The employee must be able to adhere to Current Good Manufacturing Practices (cGMP) while utilizing tools, computers, and safety devices to efficiently complete assigned work.
Based on the weight and frequency of material handling and required non-handling activities, the typical day-to-day job demands of a Quality Engineer carry the physical demand rating classification of Light.  This rating is set forth by The United States Department of Labor.*Please Note: Physical demands vary by job title, plant location, and product design.  

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