{"id":2850632,"url":"https://alion.io/job/werfen-senior-quality-engineer-ii","title":"Senior Quality Engineer II","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":"senior","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"explicit","locations":["Bedford, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":150000,"max":180000,"currency":"USD","period":"year","gross":null,"usd_annual":180000},"salary_estimate":null,"experience_years_min":10,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"Design Controls","optional":false},{"name":"Mandiant capa","optional":false},{"name":"Verification & Validation","optional":false}],"status":"live","first_seen_at":"2026-10-19T13:12:35Z","employer_posted_date":"2026-10-19","last_verified_at":"2026-10-24T02:04:08Z","board_verified":true,"closed_at":null,"days_open":4,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":4},"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 position is responsible to ensure that activities throughout the product lifecycle are in compliance with procedures, standards and regulations applicable to our products. This position provides project level leadership, independently develops, applies, and implements methods, tools and practices to achieve product quality goals and requirements in the areas of design, development, production, distribution, maintenance and service.\nThis is a technically focused role requiring advanced skills in analyzing information, reviewing technical reports, promoting process improvement, requirements development, risk management, product development and production controls. The position is expected to lead by example in alignment with the company values to achieve objectives.\nResponsibilities\nKey Accountabilities\nEssential Functions:\nParticipates in the generation and review of quality documents throughout the product lifecycle\nAdvises and directs teams regarding compliance to procedures, standards and regulations\nEnsures product quality meets requirements and documentation is complete prior to approval\nParticipates on core teams supporting new product development or design changes\nDefends relevant quality topics in audits and corrective actions to improve and maintain compliance of the QMS\nInterprets regulations and procedures to ensure documents are sound and defensible to auditors and regulatory bodies.\nOn projects of significant scope, leads successful implementation of Design Control and Product Realization requirements for design, production and distribution of IL products\nOn new product development and or product performance investigations, provides guidance on most appropriate tools and techniques available\nProvides input on product requirements, acceptance criteria, traceability, process monitoring, product evaluation, failure investigation and complaint analysis.\nEnsures application of sound statistical methods and quality tools in the evaluation and documentation of results related to design control, purchased part qualifications, V&V, risk analysis, production transfer, production, distribution and marketing of IL products.\nProvides guidance on compliance of software to procedures and standards including cyber security and privacy requirements\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. \nMay manage and supervise the work of others\nLeads cross-functional projects on technical and quality issues\nOther duties as assigned \nSecondary Functions:\nIdentifies compliance gaps and takes appropriate corrective actions as needed\nDefends documents and procedures internal and external audits\nLeads quality system improvement projects as required.\nInternal Networking/Key Relationships\nTo be determined based on department needs, to include interactions such as:\nWorks closely with other functions to generate compliant documents by interpreting and explaining quality procedures, applicable standards, regulations and best practices.\nAble to effectively communicate quality requirements to a broad population of constituents.\nAbility to negotiate and influence others in establishing direction toward improved quality and enhanced compliance.\nQualifications\nSkills & Capabilities:\nThe ideal candidate for this position will exhibit the following skills and capabilities:\nWorking knowledge of domestic and international quality/regulatory standards related to our products\nKnowledge of quality management techniques (Lean, Six Sigma) and statistical techniques required to measure and confirm significant changes.\nWorking knowledge of IL products, technology and manufacturing processes including impact on customers and patient requirements.\nDemonstrates judgement commensurate with experience regarding application of regulatory requirements to data review, reports, design changes, risk management, etc. to ensure compliance and achieving business objectives. Demonstrated understanding of risk based approach to processes and decisions.\nMinimum Knowledge & Experience required for the position:\nEducation: Bachelor's degree or equivalent in engineering or science \nExperience: A minimum of 10 years of experience in medical devices, pharmaceuticals, diagnostic industry, or clinical laboratory or 7 years of experience with an advanced degree.\nAdditional Skills/Knowledge:Duties necessitate broad and thorough knowledge of engineering and science theory and principles, including R&D, quality control, manufacturing and design engineering\nUnderstanding of the application of technical principles and engineering problem solving to resolve complex issues. \nASQ Quality Engineering Certification - Desirable\nLEAN/Six Sigma Certification - Desirable\nLanguage: English\n\nTravel Requirements: Approximately 10% of time\nThe annual base salary range for this role is currently $150,000 to $180,000. 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. Our sales roles are eligible for participation in a commission plan and our management, and select professional roles, are eligible for a performance-based bonus.\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":7510,"description_truncated":false,"requirements":{"experience_years_min":10,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":true},"security_clearance":false,"languages":[{"language":"English","level":"All levels","optional":false}]},"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":"2026-10-19T13:12:35Z"}],"visa":[],"liveness":{"score":83,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.881,"p_room":0.945,"age_days":3,"expected_fill_days":8,"reasons":["conf:2","velocity","win:mid"],"computed_at":"2026-10-23T05:54:15Z"},"pay":{"stated_usd_annual":180000,"is_top_pay":true},"html_url":"https://alion.io/job/werfen-senior-quality-engineer-ii","json_url":"https://alion.io/job/werfen-senior-quality-engineer-ii.json","meta":{"generated_at":"2026-10-24T05:15:55Z","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":7389,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-25T00:00:00Z"}},"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-senior-quality-engineer-ii"},{"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-senior-quality-engineer-ii"},{"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-senior-quality-engineer-ii"},{"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-senior-quality-engineer-ii\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fwerfen-senior-quality-engineer-ii"}]}