{"id":3706865,"url":"https://alion.io/job/werfen-quality-engineer-iii","title":"Quality Engineer III","company":{"id":1839823,"name":"Werfen","domain":"werfen.com","url":"https://alion.io/company/werfen","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"iCIMS","truth_index":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"middle","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"explicit","locations":["San Diego, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":100000,"max":125000,"currency":"USD","period":"year","gross":null,"usd_annual":125000},"salary_estimate":null,"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"21 CFR Part 820","optional":true},{"name":"CAPA","optional":true},{"name":"Design Controls","optional":true},{"name":"Design of Experiments","optional":true},{"name":"GLP","optional":true},{"name":"ISO 14971","optional":true},{"name":"Microsoft Office","optional":true},{"name":"Sterilization Validation","optional":true}],"status":"live","first_seen_at":"2026-11-03T21:25:37Z","employer_posted_date":"2026-11-03","last_verified_at":"2026-11-07T11:01:11Z","board_verified":true,"closed_at":null,"days_open":3,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":3},"description":"Introduction\nWerfen\nWerfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.\nOur success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.\nOverview\nPosition Summary:\nThe Quality Engineer III creates various quality system documents including procedures and work instructions. Quality Engineer III will support a wide range of quality-related engineering activities including, but not limited to, process development, product development, risk management, root cause investigation, risk assessments and verification/validation. The Quality Engineer III, Quality will support and/or lead continuous improvement projects and will be a key resource for the organization in the proper use of statistics including capability studies, gage R&R, test method validation and acceptance sampling plans.\nThe annual base salary range for this role is currently $100,000 to $125,000. This is a bonus-eligible position. Individual employee compensation will ultimately depend on factors including education, relevant experience, skillset, knowledge, and particular business needs.\nThis role is eligible for medical, dental, and vision insurance, 401k plan retirement benefits with an employer match, as well as paid vacation and sick leave.\nResponsibilities\nKey Accountabilities:\nWrite, review, and approve quality system documents which comply with applicable regulations and standards.\nParticipate and/or lead process validation teams. \nWork cross-functionally, as a key resource, to solve problems related to product or process quality issues; investigate non-conformances, identify root cause, and determine/implement appropriate corrective action plans.\nSupport design control project teams: ensure predetermined requirements are met and that compliance is maintained. \nParticipate in internal and external audits. \nConduct risk and trend evaluations for product non-conformances.\nMay prepare technical microbiology and sterility assurance reports and formulate microbiology or sterility assurance recommendations for disposition or other actions related to product non-conformances.\nWorks with manufacturing, R&D, Service, Distribution, Sales & Marketing, and others outside the company (as needed) to recommend or prepare corrective / preventive actions (CAPA). \nReviews and approves change orders for product performance, process changes, labeling and marketing communications as required. \nInterprets regulations and procedures to ensure documents are sound and defensible to auditors and regulatory bodies. Supports internal and external audits.\nAbility to prioritize urgent matters. \nNetworking/Key relationships:\nManufacturing/Operations\nManufacturing Engineering\nRegulatory Affairs\nResearch & Development\nService\nQualifications\nMinimum Knowledge & Experience Required for the Position:\nBachelor’s degree, or equivalent, plus a minimum of (3) to five to (5) year previous experience, preferably within a regulated medical device or pharmaceutical environment \nKnowledge of Risk Management discipline and must be able to apply quality principles (GMPs, EN ISO 14971:2012,) to the R&D environment\nASQ certification and/or Six Sigma Green/Black belt preferred\nBroad knowledge of quality engineering principles required\nBroad knowledge of Quality System Regulations required\nPrevious experience with statistical sampling and analysis, design of experiments (DOE) and validation required\nGood technical writing skills required\nGood communication and presentation skills\nKnowledge of Microsoft Office required; knowledge of statistical software, and experience with large enterprise resource planning (ERP) system required\nDemonstrated good problem solving skills required\nStrong planning and organizational skills required\nExpertise in Gamma Sterilization a plus\nAbility to lead cross functional projects to timely and effective conclusion\nAbility to collaborate internally and externally; working with vendors and subcontractors; and consultants with no supervision\nUnderstands and demonstrates aseptic technique.\nExperience with GLP principles. \nClosing\nIf you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV.\nWerfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact  for assistance.\nWe operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team.\nwww.werfen.com","description_format":"text","description_chars":5809,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":true},"security_clearance":false,"languages":[]},"benefits":["401k plan","Vision insurance"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Diagnostic Tests & IVD","Medical Supplies & Consumables"],"lifecycle":[{"event":"open","at":"2026-11-03T21:25:37Z"}],"visa":[{"country":"US","licensed_sponsor":true,"adverts_offering_sponsorship_24m":0,"sanctioned_now":false,"evidence":"H-1B filings in 12 months: 1","filings_12m":1,"filings_prev_12m":0,"green_card_filings_12m":0,"median_offered_wage_usd":82500,"route":null,"cap_exempt":false,"checked_at":"2026-11-07T07:57:00+00:00","sources":["US Department of Labor: LCA disclosure data (H-1B, H-1B1, E-3)"],"filings_for_role_12m":0}],"liveness":{"score":90,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.903,"p_room":1,"age_days":3,"expected_fill_days":12,"reasons":["conf:2","velocity","win:early"],"computed_at":"2026-11-07T05:47:08Z"},"pay":{"stated_usd_annual":125000,"is_top_pay":true},"html_url":"https://alion.io/job/werfen-quality-engineer-iii","json_url":"https://alion.io/job/werfen-quality-engineer-iii.json","meta":{"generated_at":"2026-11-07T12:39:17Z","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":14426,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-08T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"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":1839823},"rest":"https://alion.io/mcp/rest/get_company?id=1839823"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fwerfen-quality-engineer-iii"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"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%2Fwerfen-quality-engineer-iii"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"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%2Fwerfen-quality-engineer-iii"},{"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/werfen-quality-engineer-iii\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fwerfen-quality-engineer-iii"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3706865}},{"tool":"search_jobs","arguments":{"company":"werfen.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3706865},"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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