{"id":2483081,"url":"https://alion.io/job/hoya-vision-care-quality-engineer","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":75,"open_postings":10,"ghost_share":0,"stale_share":1,"repost_share":0,"time_to_fill_p50_days":27,"computed_at":"2026-10-15T05:46:00Z"}},"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":["Ramsey, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":88000,"max_usd":167000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":5578},"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"Microsoft Excel","optional":true},{"name":"Outlook","optional":true}],"status":"live","first_seen_at":"2026-10-13T20:28:27Z","employer_posted_date":"2026-10-13","last_verified_at":"2026-10-15T18:56:05Z","board_verified":true,"closed_at":null,"days_open":2,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":2},"description":"Join The HOYA Vision Care Team!\nFor over 60 years, HOYA Vision Care has been a passionate leader in optical technology innovation. As a manufacturer of high quality, high performing eyeglass lenses, we continuously aim to bring the best possible vision care solutions to eye care professionals.\nWe are currently hiring a Quality Engineer in our Ramsey, MN location!The Quality Engineer is responsible for ensuring that products, processes, and quality systems comply with internal requirements, customer expectations, and regulatory standards. The Quality Engineer will support the Quality Department in establishment, maintenance, and continuous improvement of the QMS, risk management activities, validation and qualification programs, audits, CAPA investigations, and continuous improvement initiatives in alignment with ISO 13485/FDA compliance and other applicable regulatory requirements.\nThis position will work closely with Operations, Engineering, R&D, and Global/regional Quality functions to drive product quality, process effectiveness, compliance, and customer satisfaction supporting ATC (R&D), Mass Operations, and Rx functions.\nWhat’s in it for you?\nHealth/Dental/Vision/Disability Insurance\nTuition Reimbursement\n401K plans\nPTO and Paid Holidays\nAnd more!\n\nESSENTIAL DUTIES AND RESPONSBILITIES\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\nPerform 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 other)\n\nParticipate in change management activities\n\nPerform data analysis, KPI monitoring, identify trends and opportunities for improvement\n\nDevelop PCPs and support production lines as needed\n\nEDUCATION AND QUALIFICATIONS\nBachelor’s degree (Engineering, Science, or related field preferred) or commensurate offsetting experience in Quality Engineering\n\nEXPERIENCE\n5+ years hands-on experience in medical device quality\n\nExperience with QMS development 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/ophthalmics 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","description_format":"text","description_chars":4355,"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":["401k plan"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Eyewear","Optometry & Optical 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