{"id":4291806,"url":"https://alion.io/job/tekniplex-quality-engineer-2","title":"Quality Engineer","company":{"id":2547777,"name":"TekniPlex","domain":"tekni-plex.com","url":"https://alion.io/company/tekni-plex","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"UltiPro","truth_index":{"grade":"B","score":76,"open_postings":22,"ghost_share":0,"stale_share":0.955,"repost_share":0,"time_to_fill_p50_days":26,"computed_at":"2026-11-14T05:58:10Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"junior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Madison, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":90000,"max":126500,"currency":"USD","period":"year","gross":null,"usd_annual":126500},"salary_estimate":null,"experience_years_min":2,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"21 CFR Part 820","optional":false},{"name":"CAPA","optional":false},{"name":"FMEA","optional":false},{"name":"GMP","optional":false},{"name":"ISO 13485","optional":false},{"name":"ISO 14971","optional":false},{"name":"JMP","optional":false},{"name":"Microsoft Office","optional":false},{"name":"Minitab","optional":false},{"name":"Statistical Process Control","optional":false},{"name":"Design of Experiments","optional":true}],"status":"live","first_seen_at":"2026-11-13T22:00:09Z","employer_posted_date":"2026-11-13","last_verified_at":"2026-11-14T13:28:42Z","board_verified":true,"closed_at":null,"days_open":0,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":0},"description":"Imagine: A Career with Purpose and Possibility\nPicture 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.\nAt 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.\nHere, 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.\nBecause at TekniPlex, you don’t just deliver products - you help shape what’s next.\nJob Summary:\nTekniPlex 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.\nJob Duties:\nComplaint Investigations\nLead customer complaint root cause investigations: confirm the defect, review retained samples and batch records and determine scope and risk.\nTrend complaint data by product, line, and failure mode; report recurring issues to site and corporate quality leadership.\nRoot Cause Analysis and CAPA\nLead 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.\nInitiate, own, and verify the effectiveness of corrective and preventive actions in the eQMS, keeping actions on schedule and closed with objective evidence.\nParticipate in rejected material (RJM) dispositions and manage supplier corrective action requests (SCARs), as applicable\nValidation Review and Qualification\nReview and approve IQ/OQ/PQ plans and reports for equipment, processes, and production lines, confirming acceptance criteria, sample sizes, and statistical rationale.\nSupport qualification activities for new equipment, tooling, materials, and process changes, including requalification and revalidation after change.\nReview test method validations and packaging validations, including measurement system analysis (Gage R&R), seal and barrier integrity testing, and ISO 11607 requirements where applicable.\nAssess change controls for quality and validation impact before approval.\nProcess Development and Capability Improvement\nPartner with Engineering and Operations during new product introduction and process development: process FMEA, control plans, critical-to-quality characteristics, and inspection plans.\nSupport process capability studies (Cp, Cpk, Pp, Ppk), statistical process control, and designed experiments; recommend and drive improvements where capability falls short.\nApply Lean and Six Sigma methods to reduce scrap, rework, and complaints, and lead or support continuous improvement projects.\nQuality System and Compliance\nSupport internal, customer, supplier, and regulatory audits against ISO 13485 and lead response to related findings, as applicable\nApply risk management principles (ISO 14971) to process and product changes.\nWrite and revise SOPs and work instructions and train operations and quality staff on quality requirements.\nBasic Qualifications:\nBachelor's degree, preferably in an engineering discipline (for example mechanical, industrial, chemical, polymer/plastics, biomedical, or manufacturing engineering).\nAt least 2 years of professional experience, including quality experience in a regulated field such as healthcare, medical device, or pharmaceutical manufacturing.\nAdditional Qualifications:\nHands-on experience with complaint investigations, CAPA, nonconformance handling, and root cause analysis methods, required\nUnderstanding of process validation principles (IQ/OQ/PQ) and the ability to review protocols and reports critically, required\nWorking knowledge of statistical methods: SPC, process capability, sampling plans, and measurement system analysis. Experience with Minitab, JMP, or equivalent software, required\nClear technical writing and communication skills, with the ability to explain findings to operators, engineers, customers, and auditors, required\nStrong analytical and problem-solving skills, and the ability to manage several investigations at once, required\nWorking knowledge of ISO 13485, FDA 21 CFR Part 820, and cGMP requirements, preferred\nProficiency with Microsoft Office; experience with an electronic quality management system (eQMS) is a plus.\nCertifications in any of the following are a plus:ASQ Certified Quality Engineer (CQE)\nASQ Certified Quality Auditor (CQA)\nASQ Certified Six Sigma Green Belt (CSSGB)\nASQ Certified Six Sigma Black Belt (CSSBB)\n\nExperience in medical device or healthcare packaging, plastics extrusion, converting, or similar manufacturing.\nFamiliarity with ISO 11607 and ISO 14971.\nExperience with design of experiments (DOE) and equipment or process qualification in a production setting.\nExperience hosting or supporting customer and regulatory audit.\nTekniPlex 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.\nSome 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.\nMedical Coverage\nPrescription Drug Coverage\nTelemedicine\nDental Coverage\nVision Coverage\nEmployee Assistance Program\nHealth Savings Account (HSA)\nFlexible Spending Account (FSA)\nBasic Term Life/AD&D Insurance\nVoluntary Life/AD&D Insurance\nShort Term Disability (STD)\nLong Term Disability (LTD\nVoluntary Buy-Up LTD\nHospital Indemnity\nAccident Insurance\nCritical Illness\n401(k) Retirement Savings Plan\nDaily Pay\nBusiness Travel Insurance\nLegal Plan\nIdentity Protection\nLANGUAGE SKILLS\nAbility 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.\nMATHEMATICAL SKILLS\nAbility 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.\nREASONING ABILITY\nAbility 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.\nPHYSICAL DEMANDS\nThe 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.\nWhile 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.\nWORK ENVIRONMENT\nWhile 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\nThe 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.\nEqual Opportunity Company\nTekniplex 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.","description_format":"text","description_chars":10803,"description_truncated":false,"requirements":{"experience_years_min":2,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":true},"security_clearance":false,"languages":[]},"benefits":["Life insurance","Retirement plans"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Plastics & Polymers","Packaging & Labeling","Medical Supplies & Consumables"],"lifecycle":[{"event":"open","at":"2026-11-13T23:34:29Z"}],"visa":[{"country":"US","licensed_sponsor":true,"adverts_offering_sponsorship_24m":0,"sanctioned_now":false,"evidence":"H-1B filings in 12 months: 3","filings_12m":3,"filings_prev_12m":1,"green_card_filings_12m":0,"median_offered_wage_usd":127500,"route":null,"cap_exempt":false,"checked_at":"2026-11-14T07:33:33+00:00","sources":["US Department of Labor: LCA disclosure data (H-1B, H-1B1, E-3)"],"filings_for_role_12m":0}],"liveness":{"score":60,"band":"ok","label":"Likely open","p_open":1,"p_active":0.602,"p_room":1,"age_days":0,"expected_fill_days":26,"reasons":["conf:0","stale_co","win:early","comp:junior"],"computed_at":"2026-11-14T05:58:10Z"},"pay":{"stated_usd_annual":126500,"is_top_pay":true},"html_url":"https://alion.io/job/tekniplex-quality-engineer-2","json_url":"https://alion.io/job/tekniplex-quality-engineer-2.json","meta":{"generated_at":"2026-11-14T15:30:05Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":17102,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-15T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.1,"usd":0.01,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":2547777},"rest":"https://alion.io/mcp/rest/get_company?id=2547777"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Ftekniplex-quality-engineer-2"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"free","price":{"credits":0,"usd":0},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Ftekniplex-quality-engineer-2"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.1,"usd":0.01},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Ftekniplex-quality-engineer-2"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/tekniplex-quality-engineer-2\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Ftekniplex-quality-engineer-2"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":4291806}},{"tool":"search_jobs","arguments":{"company":"tekni-plex.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":4291806},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); https://alion.io/mcp with an Alion account has everything. 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