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Quality Systems Spec

4 months ago

Madison, United States Tekni-Plex Full time

JOB DESCRIPTION

Division: Quality

Location: Madison, WI

Job Title: Quality System Specialist

Grade Level: 6

Department: Quality

FLSA Status: Non Exempt

Reports To: Quality Manager

Published Date: 05.2024

Other:

Revision: 1

JOB SUMMARY

A team leader, planner, trainer, and administrator. This role is situated for a candidate who will be the primary contact with raw material supplier, customer complaints, reviewing and adjusting SOPs, and communicating action plan with rejected materials to both internal and external customers.

DUTIES AND RESPONSIBILITIES

1. Promotes personal and product safety by:

o Constantly accessing job requirements and addresses possible job hazards by either eliminating the hazard or through implementing a requirement for PPE or possible engineering solution.

o Audits employee behaviors to ensure compliance with safety rules and guidelines.

o Drive floor level safety compliance and implement safety initiatives.

o Participates actively on the plant-wide safety teams.

2. Ensures Quality of products and processes are maintained by:

o Understands and supports the quality policies, quality systems. Reports any non-conformances or high risk quality problems to immediate supervisor.

o Reject any non-conforming material

o Block material use in PRMS

o Disposition

o What to do with RJM

o Rework or scrap material

o Communicate with Vendors if needed in SCAR process.

3. Identifies problems related to quality process and provides quality reports to assist process improvement.

o Create and/or adjust WI and SOPs as needed based on process improvements and adjustments.

4. Ensures that data collection/reporting activities within the Quality department are completed accurately and on a timely basis.

5. Customer Relationships

o Support and communicate customer investigations if complaints arise with both internal and external customers

o Preparing Samples for customers if needed

o Handle Urgent Requests for customers via proper communication channels

o Communicate with Customer Service and Customers directly to exchange information as needed and find solutions.

6. Data entry for Quality Software.

o Customer Complaints

o Audits

o SCARS

o Internal Non-Conforming materials

o CAPA projects

o Change of Management projects

7. Works closely with Manufacturing Process Engineer and QA in the development and implementation of Statistical Process Control.

8. Facilitates team improvement projects such as, but not limited to:

o Quality improvement- implementation of Statistical Process Control.

o Waste Reduction

o Compliance with Good Documentation Practice

o Procedural compliance

9. Actively participates in root cause investigations and process improvement teams.

10. Perform document audits and floor audits as needed.

11. Capable of working nights, either 2nd or 3rd shift as well as weekends as necessary.

12. Other duties as assigned.

SUPERVISORY RESPONSIBILITIES:

Does this job have supervisory responsibilities? No

Are there subordinate supervisors reporting to this job? No

QUALIFICATIONS

•Previous quality assurance experience

•Ability to input and retrieve information on a computer. Prefer Microsoft Excel skills.

•Basic understanding of equipment, instruments and processes.

•Good communication and interpersonal skills using tact and diplomacy.

•Strong attention to detail.

•High School graduate or equivalent GED certification with 18 months related work experience.

•3-5 years experience in a Quality Control or Quality Assurance Organization.

•1-3years experienceworking in an ISO 9001 or ISO 15378or ISO 13485certified manufacturing environment is desirable

•Must be self directed with leadership qualities and a good example for safety and cGMP rules.

•Experience with customer facing role, both internal and external

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 will be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to stand, walk, and talk or hear. The employee frequently is required to use hands to finger, handle, or feel and reach with hands and arms. The employee is occasionally required to sit; climb or balance; stoop, kneel, crouch, or crawl; and taste or smell. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.

WORK ENVIRONMENT

While performing the duties of this job, the employee is frequently exposed to moving mechanical parts and vibration. The employee is occasionally exposed to high, precarious places; fumes or airborne particles; toxic, flammable or caustic chemicals; outside weather conditions; and extreme heat. The noise level in the work environment is usually moderate

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

Equal Opportunity Company

Tekniplex is proud to be an Equal Opportunity Employer. Our hiring practices provide equal opportunity for employment without regard to race, religion, color, sex, gender, national origin, age, United States military veteran's status, ancestry, sexual orientation, marital status, family structure, medical condition including genetic characteristics or information, veteran status, or mental or physical disability so long as the essential functions of the job can be performed with or without reasonable accommodation, or any other protected category under federal, state, or local law.