{"id":3503268,"url":"https://alion.io/job/hoya-vision-care-quality-engineer-2","title":"Quality Engineer","company":{"id":450913,"name":"HOYA Vision Care","domain":"hoyavision.com","url":"https://alion.io/company/hoya-vision","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Oracle","truth_index":{"grade":"B","score":81,"open_postings":13,"ghost_share":0,"stale_share":0.769,"repost_share":0,"time_to_fill_p50_days":27,"computed_at":"2026-11-02T06:13:15Z"}},"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":"structured","locations":["Lewisville, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":81000,"max_usd":154000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":6333},"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"Design History File","optional":false},{"name":"FMEA","optional":false},{"name":"ISO 13485","optional":false},{"name":"21 CFR Part 820","optional":true},{"name":"ISO 14971","optional":true},{"name":"Microsoft Excel","optional":true},{"name":"Minitab","optional":true},{"name":"Outlook","optional":true}],"status":"live","first_seen_at":"2026-10-29T22:31:26Z","employer_posted_date":"2026-10-29","last_verified_at":"2026-11-01T11:45:30Z","board_verified":true,"closed_at":null,"days_open":3,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":3},"description":"ESSENTIAL DUTIES AND RESPONSIBILITIES \nSupport the Quality Team with QMS establishment, maintenance, and continuous improvement\n\nCollaborate with cross-functional teams to provide quality leadership, guidance, training, and support in QMS implementation/execution.\n\nSupport validation activities, including IQ/OQ/PQ and TMV for equipment and production line process validation\n\nSupport software validation and computer systems validation activities as required\n\nOwn and support CAPAs, deviation, and nonconformance investigations\n\nConduct risk assessments and lead failure mode and effects analysis (FMEA) activities. Ensure risks are identified, evaluated, mitigated, and documented\n\nDevelop documentation (i.e., quality plans, procedures) to ensure compliance with applicable regulations\n\nServe as the quality representative on Design and Development projects supporting completion of DHF documentation\n\nMay perform internal QMS/process audits and support external audits (i.e., ISO 9001, ISO 13485, FDA) to ensure compliance with quality and regulatory requirements\n\nSupport supplier quality evaluations and monitoring (audits, SCAR, and others)\n\nParticipate in change management activities\n\nPerform data analysis and KPI monitoring to identify trends and opportunities for improvement.\n\nAll other duties as assigned.\n\nKEY COMPETENCIES\nTo perform the job successfully, an individual should demonstrate the following competencies:\nIndependence-Must have the ability to work independently and be able to step outside of your comfort zone for the purposes of QMS Module development and support: proactively takes on new tasks and sees them through to completion, escalates issues/roadblocks as appropriate\n\nTraining-Must be comfortable training other employees, including leadership teams, on newly implemented QMS modules as well as other quality-related topics\n\nSafety-Implement safety practices into daily workload to protect self and others\nCustomer Service-Responds promptly to customer needs; responds to requests for service and assistance\nInterpersonal Skills-Able to communicate within the team and cross-functionally\nEthics-Works with integrity and ethics; upholds organizational values\nOrganizational Support-Completes tasks correctly and on time\nPlanning/Organizing-Prioritizes and plans work activities; uses time efficiently\nQuality-Demonstrates accuracy and thoroughness; looks for ways to improve and promote quality; monitors own work to ensure quality and compliance\nQuantity-Meets productivity standards; completes work in a timely manner\nAttendance/Punctuality-Is consistently at work and on time\nDependability-Follows instructions, responds to management direction, takes responsibility for own actions, and completes tasks on time or notifies the appropriate person with an alternate plan\nOral Communication-Listens and gets clarification; responds well to questions\nTeamwork-Balances team and individual responsibilities; exhibits objectivity and openness to others' views; gives and welcomes feedback; contributes to building a positive team spirit\nDiversity-Shows respect and sensitivity for cultural differences; educates others on the value of diversity; promotes a harassment-free environment; builds a diverse workforce\n\nEDUCATION AND QUALIFICATIONS\nBachelor’s degree (engineering, science, or a related field preferred) or commensurate offsetting experience in quality engineering.\n\nEXPERIENCE\n5+ years of hands-on experience in medical device quality engineering\n\nExperience with QMS development and implementation is a plus\n\nExperience with FDA-regulated products and ISO 13485 certified QMS\n\nExperience in product development, including implementing appropriate controls\n\nWorking knowledge of statistics is required, with Six Sigma Green Belt (or higher) certification being a plus\n\nWorking knowledge of FDA regulations (21 CFR 820) and other relevant standards is strongly preferred\n\nExperience in a medical device start-up environment is strongly preferred\n\nASQ certification as a Quality Engineer is a plus\n\nExperience in performing QMS audits is preferred, with certification as a Quality Auditor being a plus\n\nExperience in optics/ophthalmic is a plus\n\nProficiency with Minitab, MS Outlook, MS Word, and MS Excel\n\nExperience with ISO 14971 risk management is a plus\nDEMONSTRATED ABILITIES\nAttention to detail and excellent problem-solving skills\n\nExcellent written and verbal communication skills\n\nAbility to identify potential roadblocks and provide innovative solutions\n\nAbility to work independently and in a collaborative team environment\n\nOperate with a high level of integrity and professionalism\n\nAbility to learn new software programs as required\n\nAbility to travel up to 10%\n\nHumble, hungry, and People-smart with a willingness to learn and grow\n\nFind fulfillment in building and maintaining QMS’s and supporting a quality culture\n\nThrive in a dynamic environment with continually shifting priorities\n\nAbility to manage communication and training with knowledge of different training techniques\n\nWORK ENVIRONMENT\nEnvironmental: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.\nPhysical: While performing the duties of this job, the employee must occasionally lift and/or move up to 30 pounds.\n\nPHYSICAL DEMANDS\nWhile performing the duties of this job, the employee is regularly required to sit and to use hands to grasp and manipulate.The job requires working near moving mechanical parts, fumes or airborne particles, UV rays, and toxic or caustic chemicals. The work environment noise level is usually moderate.\nSAFETY REQUIREMENTS\nBasic understanding of the Injury and Illness Prevention Program and the Hazard Communication Program\n\nClosed-toe shoes with heel support may be required where needed\n\nWhile performing the duties of this job, the employee is occasionally exposed to moving mechanical parts. The noise level in the work environment may require P.P.E.\n\nSafety glasses and long-sleeve shirts may be required where needed","description_format":"text","description_chars":6203,"description_truncated":false,"requirements":{"experience_years_min":5,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":true},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Eyewear","Optometry & Optical Stores"],"lifecycle":[{"event":"open","at":"2026-10-30T04:38:12Z"}],"visa":[],"liveness":{"score":60,"band":"ok","label":"Likely open","p_open":1,"p_active":0.602,"p_room":1,"age_days":3,"expected_fill_days":27,"reasons":["conf:18","stale_co","win:early"],"computed_at":"2026-11-02T06:13:15Z"},"pay":null,"html_url":"https://alion.io/job/hoya-vision-care-quality-engineer-2","json_url":"https://alion.io/job/hoya-vision-care-quality-engineer-2.json","meta":{"generated_at":"2026-11-02T10:15:09Z","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":14253,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-03T00:00:00Z"}},"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":450913},"rest":"https://alion.io/mcp/rest/get_company?id=450913"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fhoya-vision-care-quality-engineer-2"},{"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%2Fhoya-vision-care-quality-engineer-2"},{"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%2Fhoya-vision-care-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/hoya-vision-care-quality-engineer-2\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fhoya-vision-care-quality-engineer-2"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3503268}},{"tool":"search_jobs","arguments":{"company":"hoyavision.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3503268},"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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