Quality Systems Specialist

TekniPlex•Madison, WI

15h•$28 - $31•Onsite

About The Position

TekniPlex is hiring a Quality Systems Specialist for our Madison, WI facility. 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. The pay range for this role is $27.69 to $31.01 per hour.

Requirements

High School diploma or equivalent GED certification
18 months related work experience is a plus
3-5 years’ experience in a Quality Control or Quality Assurance Organization is a plus
1-3 years’ experience working in an ISO 13485, or similar experience including ISO 9001 or ISO 15378, certified 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
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.
Ability to read and interpret documents such as safety rules, operating and maintenance instructions and procedure manuals.
Ability to write routine reports and legibly complete time cards and work orders.
Ability to read, analyze, and interpret technical procedures and read blueprints and technical drawings, such as machine, mechanical, pneumatic, hydraulic, and electrical.
Ability to effectively present information in one-on-one and small groups situations to other employees of the organization.
Ability to effective present information and respond to questions form groups of managers, clients, customers, and the general public.
Ability to add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions, and decimals.
Ability to compute rate, ratio, and percent.
Ability to apply concepts of basic algebra, geometry, fractions, percentages, ratios, and proportions to practical situations.
Ability to solve practical problems and deal with a variety of variable in situations where only limited standardization exists.
Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
Ability to define problems, collect data, establish facts, and draw valid conclusions.
Ability to interpret an extensive variety of technical instructions in mathematical or diagram form.

Responsibilities

Maintain and improve the site’s Quality Management System in alignment with ISO 13485 requirements
Administer document control processes, including creation, revision, approval, and archival of controlled documents
Support internal and external audits, including preparation, execution, and follow-up on audit findings
Lead and/or support Corrective and Preventive Actions (CAPA), ensuring timely and effective resolution
Manage nonconformance processes, including investigation, documentation, and disposition
Assist with training program administration to ensure employees are trained and compliant with QMS requirements
Support risk management activities and ensure proper documentation in accordance with applicable standards
Monitor quality system metrics and generate reports to support management review
Collaborate cross-functionally with manufacturing, engineering, and other departments to drive quality improvements
Ensure compliance with data integrity principles (e.g., ALCOA++) and good documentation practices
Participate in change control processes, assessing impact and ensuring proper implementation