Quality Assurance Engineer Level I-III

JOB SUMMARY:

The Quality Engineer acts as a key customer contact for all quality related issues within operations. This position will work collaboratively with the Certified Floor Auditor Level III acting as Lead customer contact. All levels will work collaboratively with the CFA 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. All levels will help address preventative action requirements in order to avoid nonconformance and ensure that end products meet/exceed customer specification by formulating operating practices (Level Is and IIs) and formulating six sigma practices (Level IIIs).

Job Title: Quality Assurance Engineer Levels I-III

Status: Salaried/Exempt

Department: Quality

Reports to: Director of Quality

DUTIES AND RESPONSIBILITIES:

%Time Level I% Time Level II% Time Level IIIEssential/Non-Essential
1. Leads continuous improvement efforts within the manufacturing cell. Analyzes data to determine appropriate root cause and corrective actions needed.30E
2. Responsible for review and dispositions of non-conforming product.5N
3. Develops qualification protocols and control plans to meet all customer requirements while minimizing scrap and eliminating customer returns.30E
4. Verifies that all appropriate instructions are in place to meet customer, FDA and/or other outside agencies requirements.15E
5. Supports CFA Level III and Quality Layout Technicians by creating and explaining procedures and quality standards.20E
6. Leads continuous improvement efforts within the manufacturing cell. Analyzes data to determine appropriate Root cause and corrective actions needed.303050E
7. Supports/Leads Audit (Regulatory or Customer) interface within the assigned customer or manufacturing cell.20205N
8. Develops strategies and uses tools in order to manage multiple customer specific projects to meet key metrics of on time delivery and overall product quality.3030
E
9. Verifies that all appropriate instructions are in place to meet customer, FDA and/or other outside agencies.155E
10. Supports CFA Level III Quality Layout Technicians and Quality Engineer I by creating and explaining procedures and quality standards.2010E

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 (Level II: 10+ years’ experience and Level III: 15+ years’ manufacturing 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. Level II: Six-sigma experience green belt
  3. Level III: Six-sigma

COMPETENCIES:

Individuals should posses 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.

PHYSICAL DEMANDS:

  1. 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. Have the ability to lift, lower and carry 1-10 lbs. on a frequent basis (up to half of your day) and 11-25 lbs. on an
    occasional basis (up to 1/3 of your day).
  2. Be able to seize, hold, pinch and grasp items typical of this job with good dexterity with both hands, such as
    tweezers, nippers and small cutting tools.
  3. Be able to crawl, crouch, stoop, kneel and bend forward/sideways without aids/assistive devices on an occasional
    basis (up to 1/3 of your day).
  4. Have the ability to work in a standing position on a frequent basis (up to half of your day). However, the duration
    may be up to the scheduled work hours. Sitting may be required on an occasional basis.
  5. Have specific vision abilities required by this job. They include color and shading discrimination, 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.
  6. Be able to adhere to all safety procedures and practices.
  7. Be able to adhere to Current Good Manufacturing Practices (cGMP) to efficiently complete assigned work while
    utilizing tools, computers, and safety devices.

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 to 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.

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 exposed to:

  1. Heavy vibration on a frequent basis (up to half of your day)
  2. Proximity to moving mechanical parts on a frequent basis (up to half of your day)
  3. Noise level intensity of moderate (manufacturing floor)
  4. May be required to work in a controlled environment requiring special garb (ex. coat, hair net, facial hair guard), gloves and prohibiting specific items on an occasional basis (up to 1/3 of your day).

Reasonable accommodation(s) will be made to enable individuals with disabilities to perform the essential functions of the position to the extent the accommodation(s) can be made without imposing an undue hardship on Tessy.

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