{"id":3526601,"url":"https://alion.io/job/cretex-quality-engineer-ii-2","title":"Quality Engineer II","company":{"id":4423483,"name":"Cretex","domain":"cretex.com","url":"https://alion.io/company/cretex","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":"structured","locations":["Lima, Peru"],"countries":["PE"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":24000,"max_usd":53000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":5668},"experience_years_min":4,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"21 CFR Part 820","optional":false},{"name":"CAPA","optional":false},{"name":"FMEA","optional":false},{"name":"ISO 13485","optional":false},{"name":"Microsoft Office","optional":false}],"status":"live","first_seen_at":"2026-10-30T14:24:44Z","employer_posted_date":"2026-10-30","last_verified_at":"2026-11-01T13:26:28Z","board_verified":true,"closed_at":null,"days_open":1,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":1},"description":"Overview\nPosition summary\nThe Quality Engineer II is primarily responsible for supporting sustaining quality activities for existing manufacturing processes and products, ensuring continued compliance with customer, regulatory, and Quality Management System (QMS) requirements. This role serves as a key quality resource for manufacturing operations, including nonconformance investigations, corrective and preventive actions, process monitoring, risk management, and continuous improvement initiatives.\nAdditionally, the Quality Engineer II supports New Product Introduction (NPI), product transfers, process validations, and other quality engineering projects as needed based on business priorities. The position works collaboratively with cross-functional teams to maintain and improve product quality, process effectiveness, and compliance within a fast-paced, growing manufacturing environment.\nResponsibilities\nEssential Job Functions\nServe as the primary quality engineering interface for assigned manufacturing operations, providing ongoing support for product quality, process performance, and issue resolution.\nLead and/or support nonconformance investigations, root cause analysis, corrective and preventive actions (CAPA), and implementation of appropriate corrective measures.\nLead and/or support customer complaint investigations, ensuring timely resolution and appropriate documentation.\nMonitor and analyze manufacturing quality data, process performance, and quality trends to identify opportunities for improvement and prevent recurring issues.\nSupport the maintenance and improvement of process controls, inspection methods, sampling plans, and acceptance criteria.\nSupport manufacturing process changes, equipment changes, and process improvements, including risk assessments, qualification, and revalidation activities as applicable.\nMaintain and update process risk management documentation, including PFMEAs and control plans, in collaboration with cross-functional teams.\nCollaborate with Manufacturing, Engineering, and other departments to resolve quality issues and implement sustainable improvements.\nIdentify, recommend, and implement continuous improvement initiatives to enhance product quality, manufacturing performance, and process effectiveness.\nSupport and/or lead assigned NPI and product transfer activities as needed, ensuring compliance with applicable customer, regulatory, and internal requirements.\nDevelop, execute, and/or support process validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), as applicable.\nParticipate in the development and review of inspection strategies, sampling plans, acceptance criteria, PFMEAs, and control plans for new or transferred products.\nCollaborate with cross-functional teams to support production readiness and successful transition of new or transferred products into routine manufacturing.\nContribute to the implementation, maintenance, and continuous improvement of the Quality Management System (QMS).\nSupport internal, customer, and regulatory audits, including audit preparation, execution, and follow-up activities.\nParticipate in supplier quality activities, including supplier investigations, qualification, and performance monitoring, as required.\nSupport environmental monitoring, calibration systems, document control, and other quality system processes, as applicable.\nEnsure compliance with applicable regulatory requirements, customer specifications, and internal quality standards.\nSupport the implementation, maintenance, and effective use of quality-related business systems.\nPromote a culture of quality, compliance, and continuous improvement across the organization.\nProvide technical guidance and support to quality personnel and cross-functional teams, as appropriate.\nParticipate in cross-functional projects, providing quality engineering expertise and recommendations.\nCollaborate with sister companies and other business units to share and implement applicable best practices.\nRead, understand, and follow applicable procedures, work instructions, and standard work.\nPerform other quality engineering responsibilities as assigned, based on business needs and priorities.\nQualifications\nMinimum Requirements, Education & Experience (incl. KSA’s and certifications)\nBachelor’s degree in Engineering or related technical field (Mechanical, Industrial, Biomedical, or similar)\n4+ years of experience in quality engineering within the medical device or regulated manufacturing industry.\nBilingual English Spanish, advanced level (B2+ minimum)\nDemonstrated experience in:\nManufacturing quality and sustaining engineering activities.\nNonconformance investigations, root cause analysis, and CAPA.\nProcess monitoring, quality data analysis, and continuous improvement.\nProcess validation (IQ/OQ/PQ).\nRisk management tools, including PFMEA and control plans.\nStrong knowledge of:\nISO 13485 and FDA 21 CFR 820 requirements\nStatistical methods and quality tools\nInspection methods, sampling plans, and manufacturing process controls.\nExperience in different manufacturing environments (machining, molding, assembly, or similar)\nStrong problem-solving, communication, and leadership skills\nAbility to work effectively in a startup or fast-paced environment\nProficiency in Microsoft Office tools\nClear and effective verbal and written communication skills\nDesirable Criteria & Qualifications\nExperience supporting New Product Introduction (NPI) and product transfer activities.\nExperience in supplier quality and internal or external audit activities.\nASQ certification (e.g., CQE, CQA)\nISO13485 Internal Auditor certification.\nExperience implementing or improving QMS systems in a startup or scaling environment\nFamiliarity with ERP/MES systems (e.g., Epicor) and data analysis tools\nExperience with manufacturing process changes, equipment qualification, and process revalidation.\nCompany 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