Quality Systems Specialist

JOB SUMMARY 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. DUTIES AND 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 QUALIFICATIONS Bachelor's or associate degree Experience with customer facing role, both internal and external 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 or other regulated environment, certified manufacturing environment is desirable Must be self-directed with leadership qualities and a good example for safety and cGMP rules 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. BENEFITS Medical Coverage Prescription Drug Coverage Vision Coverage Employee Assistance Program Health Savings Account (HSA) Flexible Spending Account (FSA) Basic Term Life/AD&D Insurance Voluntary Life/AD&D Insurance Short Term Disability (STD) Long Term Disability (LTD Voluntary Buy-Up LTD Hospital Indemnity Critical Illness 401(k) Retirement Savings Plan Daily Pay Business Travel Insurance Legal Plan Identity Protection LANGUAGE SKILLS 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 from groups of managers, clients, customers, and the general public. MATHEMATICAL SKILLS 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. REASONING ABILITY 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. 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 EMPLOYER 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. Equal Opportunity Employer This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor. #J-18808-Ljbffr