Quality Engineer

Imagine: A Career with Purpose and Possibility

Picture this: You are part of a global team of problem-solvers whose innovations in materials science can make life better. Every day, you help turn ideas into impact using science, technology, and creativity to tackle real-world challenges. You are part of a company whose work helps improve patient outcomes in healthcare and protects essential consumer goods that people around the world rely on every day.

At TekniPlex, you’ll join more than 8,000 colleagues across 12 countries, all united by one purpose: creating safer, smarter solutions that touch daily life. Through our two divisions, TekniPlex Healthcare and TekniPlex Consumer Products, you’ll help shape industries that matter: healthcare, pharmaceutical, food & beverage, beauty, and personal care.

Here, your ideas count and your work matters. You’ll be encouraged to think boldly, collaborate across cultures, and keep growing every step of the way. You will help protect the integrity of essential products, support patient safety and comfort, and contribute to innovations that make everyday life better, all while building a career that makes an impact.

Because at TekniPlex, you don’t just deliver products – you help shape what’s next.

Job Summary:

TekniPlex is hiring a Quality Engineer for our Madison, WI facility. This role is responsible for driving product and process quality through complaint investigations, root cause analysis, and corrective and preventive actions (CAPA). This role partners with Engineering, Operations, and Quality teams to identify and resolve quality issues, support equipment and process validations, improve process capability, and implement continuous improvement initiatives. The Quality Engineer also supports compliance with applicable quality standards and regulatory requirements, including ISO 13485 and ISO 14971, while maintaining effective quality systems, supporting audits, and promoting consistent product quality and operational excellence. The salary range for this role is $90,000 to $126,500 annually. Pay is based on experience.

Job Duties:

Complaint Investigations

• Lead customer complaint root cause investigations: confirm the defect, review retained samples and batch records and determine scope and risk.
• Trend complaint data by product, line, and failure mode; report recurring issues to site and corporate quality leadership.

Root Cause Analysis and CAPA

• Lead structured root cause analysis for complaints, nonconformances, audit findings, and process deviations, using tools such as 5-Why, fishbone, 8D, fault tree, and FMEA review.
• Initiate, own, and verify the effectiveness of corrective and preventive actions in the eQMS, keeping actions on schedule and closed with objective evidence.
• Participate in rejected material (RJM) dispositions and manage supplier corrective action requests (SCARs), as applicable

Validation Review and Qualification

• Review and approve IQ/OQ/PQ plans and reports for equipment, processes, and production lines, confirming acceptance criteria, sample sizes, and statistical rationale.
• Support qualification activities for new equipment, tooling, materials, and process changes, including requalification and revalidation after change.
• Review test method validations and packaging validations, including measurement system analysis (Gage R&R), seal and barrier integrity testing, and ISO 11607 requirements where applicable.
• Assess change controls for quality and validation impact before approval.

Process Development and Capability Improvement

• Partner with Engineering and Operations during new product introduction and process development: process FMEA, control plans, critical-to-quality characteristics, and inspection plans.
• Support process capability studies (Cp, Cpk, Pp, Ppk), statistical process control, and designed experiments; recommend and drive improvements where capability falls short.
• Apply Lean and Six Sigma methods to reduce scrap, rework, and complaints, and lead or support continuous improvement projects.

Quality System and Compliance

• Support internal, customer, supplier, and regulatory audits against ISO 13485 and lead response to related findings, as applicable
• Apply risk management principles (ISO 14971) to process and product changes.
• Write and revise SOPs and work instructions and train operations and quality staff on quality requirements.

Basic Qualifications:

• Bachelor's degree, preferably in an engineering discipline (for example mechanical, industrial, chemical, polymer/plastics, biomedical, or manufacturing engineering).
• At least 2 years of professional experience, including quality experience in a regulated field such as healthcare, medical device, or pharmaceutical manufacturing.

Additional Qualifications:

• Hands-on experience with complaint investigations, CAPA, nonconformance handling, and root cause analysis methods, required
• Understanding of process validation principles (IQ/OQ/PQ) and the ability to review protocols and reports critically, required
• Working knowledge of statistical methods: SPC, process capability, sampling plans, and measurement system analysis. Experience with Minitab, JMP, or equivalent software, required
• Clear technical writing and communication skills, with the ability to explain findings to operators, engineers, customers, and auditors, required
• Strong analytical and problem-solving skills, and the ability to manage several investigations at once, required
• Working knowledge of ISO 13485, FDA 21 CFR Part 820, and cGMP requirements, preferred
• Proficiency with Microsoft Office; experience with an electronic quality management system (eQMS) is a plus.
• Certifications in any of the following are a plus:
• ASQ Certified Quality Engineer (CQE)
• ASQ Certified Quality Auditor (CQA)
• ASQ Certified Six Sigma Green Belt (CSSGB)
• ASQ Certified Six Sigma Black Belt (CSSBB)
• Experience in medical device or healthcare packaging, plastics extrusion, converting, or similar manufacturing.
• Familiarity with ISO 11607 and ISO 14971.
• Experience with design of experiments (DOE) and equipment or process qualification in a production setting.
• Experience hosting or supporting customer and regulatory audit.

TekniPlex provides a comprehensive and flexible benefits program that you can customize to fit your personal needs. Our programs offer you and your family health care coverage and financial security. You can take advantage of life insurance, disability coverage and voluntary benefits for extra financial protection and peace of mind. Plus, our work-life benefits provide support and assistance whenever you need it.

Some of your benefits are paid in full by TekniPlex and some costs are shared between you and TekniPlex. Other benefits are made available to you at reasonable group rates.

• Medical Coverage
• Prescription Drug Coverage
• Telemedicine
• Dental 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
• Accident Insurance
• 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 form 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 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.