{"id":2958028,"url":"https://alion.io/job/laborie-senior-quality-engineer","title":"Senior Quality Engineer","company":{"id":2295654,"name":"Laborie","domain":"laborie.com","url":"https://alion.io/company/laborie-com","size_band":"51-200","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Jobvite","truth_index":{"grade":"A","score":86,"open_postings":4,"ghost_share":0.25,"stale_share":0,"repost_share":0.25,"time_to_fill_p50_days":11,"computed_at":"2026-10-23T05:54:15Z"}},"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":["Portsmouth, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":87000,"max_usd":165000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":5966},"experience_years_min":8,"visa_sponsorship":true,"relocation_package":false,"has_equity":false,"technologies":[{"name":"21 CFR Part 820","optional":false},{"name":"ISO 14971","optional":false}],"status":"live","first_seen_at":"2026-10-20T22:06:02Z","employer_posted_date":"2026-10-20","last_verified_at":"2026-10-23T18:02:31Z","board_verified":true,"closed_at":null,"days_open":2,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":2},"description":"We believe that great healthcare is an essential safeguard of human dignity.\nAt Laborie, we know the work we do matters - it’s what fuels our motivation and contributes to our success. If you’re ready to make a positive impact in the lives of patients across the globe, we’d like to meet you.\nWe support and empower our employees to grow their careers in an environment that encourages a sense of belonging and a connection to doing good. We’re not afraid to roll up our sleeves to make our goals a reality and work together to solve for our customers. We reward and recognize our employees based on our values of Aspire to Greatness, Respect All, Own It, Working Together, Persist with Passion.\nWho We’re Looking For:\nThe Senior Quality Engineer serves as a site or product-specific subject matter expert (SME) and mentor for junior team members. This role ensures that the technical regulatory and quality requirements are met both within the Quality Management System and throughout the product life cycle. Additionally, the Senior Quality Engineer drives strategic quality initiatives and ensures compliance with high standards.\nAbout the Role:\nProvide leadership and Subject Matter Expertise (SME) to Quality Engineering function and mentor less experienced Quality personnel. \nDevelop strategies for validation of manufacturing processes, test methods, and quality processes. \nLead Nonconforming product investigation, disposition, and approval with sound root cause analysis techniques that are well documented. \nLead and support design/development activities for new or modified products and processes, including design transfer. \nManage regulatory and quality projects with external agencies and test labs to ensure that the appropriate certification and testing is performed. \nRepresent quality in the review and approval of proposed change orders, and deviations to determine the effect of the proposed changes on materials, products and processes. \nDevelop, plan, and perform product, process monitoring & measurement activities.\nInvestigate proposed process/product changes to ensure continued safety and quality.\nPerform investigations related to complaints and/or service. \nMaintain a thorough knowledge of current QSR and ISO requirements as they apply to the medical device industry.\nDevelop and institute statistical techniques and trending to identify potential corrective or preventive actions.\nInitiate, plan, and perform corrective and preventative actions. Ensure timely resolution of corrective actions and preventive actions.\nProvide leadership and Subject Matter Expertise (SME) to Quality Engineering function and mentor less experienced Quality personnel.\nCollaborate with design team personnel in the development of new products, utilizing engineering skills.\nRepresent quality in the review and approval of proposed change orders, and deviations to determine the effect of the proposed changes on materials, products and processes.\nRecommend and implement process and product changes/improvements.\nAssist in the design/development activities for new or modified products and processes, including design transfer.\nValidate manufacturing processes, test methods, and quality processes as requested.\nManage regulatory and quality projects with external agencies and test labs to ensure that the appropriate certification and testing is performed.\nPerform and document risk analysis and make decisions based on risk management principles.\nMaintain Risk Management File for assigned Laborie products. \nMinimum Qualifications:\nMinimum 8 years of experience working in technical medical device quality and compliance roles and a bachelor’s degree in an engineering or related scientific field. \nMinimum 6 years’ experience working in technical medical device quality and compliance roles with a master’s degree in an engineering or related scientific field. \nMust possess the ability to write clear, concise and effective reports and procedures, learn quickly with guidance and training and work with minimal direct supervision. \nComputer literacy with experience in spreadsheet, database and word-processing applications. \nProcessing and product evaluation experience. \nKnowledgeable of Quality System Regulation (CFR 820) and ISO requirements. \nMust be capable of establishing and maintaining an effective working relationship with manufacturing and technical personnel at all levels. \nStrong project management and organizational skills \nProven track record of leadership \nExcellent communication and problem-solving skills \nStrong conflict resolution skills \nProficient in quality tools \nExperience with Risk Management (ISO 14971 preferred). \nExperience with quality audits (lead auditor certification preferred).\nASQ certification is preferred.\nLean Six Sigma training preferred \nWhy Laborie:\nOur Mission every day is to operate as a world-class specialist medical company making and advancing technologies that preserve and restore human dignity. We do that today by helping people with pelvic and gastrointestinal conditions live normal lives, and by helping mothers and babies have safe deliveries. \nPaid time off and paid volunteer time\nMedical, Dental, Vision and Flexible Spending Account\nHealth Savings Account with Company Funded Contributions \n401k Retirement Plan with Company Match\nParental Leave and Adoption Services\nHealth and Wellness Programs and Events\nWe are interested in a qualified candidate who is eligible to work in the United States. However, we will not be sponsoring work visas for this position, at this time.\nLaborieprovides equal employment opportunities and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation, or any characteristic protected under applicable law. Laborie is committed to providing access and reasonable accommodation in our services, activities, education, and employment for individuals with disabilities.","description_format":"text","description_chars":6054,"description_truncated":false,"requirements":{"experience_years_min":8,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["401k plan","Parental leave","Retirement plans","Wellness"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Consumer Electronics","Health Care","Surgical Instruments & Devices","Cardiovascular Devices"],"lifecycle":[{"event":"open","at":"2026-10-20T22:06:02Z"}],"visa":[],"liveness":{"score":90,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.903,"p_room":1,"age_days":2,"expected_fill_days":11,"reasons":["conf:2","velocity","win:early"],"computed_at":"2026-10-23T05:54:15Z"},"pay":null,"html_url":"https://alion.io/job/laborie-senior-quality-engineer","json_url":"https://alion.io/job/laborie-senior-quality-engineer.json","meta":{"generated_at":"2026-10-23T21:04:12Z","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":2880,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-24T00:00:00Z"}},"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":2295654},"rest":"https://alion.io/mcp/rest/get_company?id=2295654"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Flaborie-senior-quality-engineer"},{"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%2Flaborie-senior-quality-engineer"},{"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%2Flaborie-senior-quality-engineer"},{"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/laborie-senior-quality-engineer\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Flaborie-senior-quality-engineer"}]}