{"id":4173037,"url":"https://alion.io/job/ogt-quality-assurance-associate","title":"Quality Assurance Associate","company":{"id":679753,"name":"OGT","domain":"ogt.com","url":"https://alion.io/company/ogt","size_band":"201-500","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","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":["Cambridge, United Kingdom"],"countries":["GB"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":3,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"ISO 13485","optional":false},{"name":"IVDR","optional":false},{"name":"Power BI","optional":true}],"status":"live","first_seen_at":"2026-11-12T14:26:38Z","employer_posted_date":"2026-11-12","last_verified_at":"2026-11-12T15:17:08Z","board_verified":true,"closed_at":null,"days_open":0,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":0},"description":"OGT is a leading global provider of clinical and diagnostic genomic solutions. Webelievein creating products and partnerships that enable clinicians to deliver personalised healthcare to patients and that empower clinical researchers to develop the next generation ofprecisionmedicines.\nWe are looking for a proactive and detail-oriented Quality Assurance Associate to join our Cambridge-based Quality function within a regulated medical device manufacturing environment operating to ISO 13485, MDSAP, EU IVDR and FDA requirements.\nYou will combine strong technical and analytical thinking with excellent interpersonal skills. You will need to be comfortable working with controlled processes, procedures, records and data, with the attention to detail and critical thinking necessary to identify inconsistencies, investigate issues and ensure that quality principles are applied.\nThe role requires an individual who can build positive relationships with colleagues across Quality, Manufacturing, Operations, R&D and other functions. You should be able to explain quality requirements clearly, listen to different perspectives and challenge constructively.\nYou'll need to be organised and resilient, comfortable juggling multiple priorities and able to take ownership of actions through to completion.\nYour duties will include:\nQuality Management System\nMaintenance and administration of the Quality Management System, including the establishment and maintenance of core quality SOPs\nAssisting in implementing the eQMS\nSupporting quality processes including:Internal and external auditing\nSupplier control and performance monitoring\nInduction and training\nHandling of external party enquiries and data requests\n\nMonitoring of QMS performance through:Input into the definition of quality objective and KPI metrics\nMonitoring, analysis and reporting on quality KPIs\nReporting & action on KPIs through the Quality Management Review framework\n\nSupporting continuous improvement through the implementation of delegated tasks in the Quality Plan & Quality Events.\nProduct and Processes Quality Events\nProviding administrative support to quality events investigations:\nParticipation in product and process quality event investigations root cause analysis and corrective action.\nMonitoring actions status for the resolution of QMS process related Quality Events\nAssisting in the administration of quality event meetings\nAssisting the QC function in document audit for batch release.\nProduction Process Support\nProviding administrative support toEquipment Qualification tasks, including maintenance and calibration\nProcess Validation tasks\nSoftware Validation tasks.\n\nWhat we’re looking for in you:\nEssential\nDegree in a science related subject, biology based or similar discipline or equivalent experience\n3 - 5 years’ experience working in a Quality Assurance role preferably within a regulated industry to ISO 13485 / 9001\nStrong attention to detail, with the ability to review documents and data for accuracy, completeness and compliance.\nStrong written and verbal communication skills, including the ability to explain quality requirements clearly and professionally.\nEffective interpersonal skills, with the confidence to ask questions, constructively challenge and work collaboratively across different functions and levels of the organisation.\nCompetent computer skills and confidence using Microsoft 365, particularly Word and Excel, such as reviewing and formatting of controlled documents, formulas and analysis of data\nGood organisation and time-management skills, with the ability to manage multiple activities, deadlines and changing priorities.\nDesirable\nExperience with eQMS and ERP systems\nExperience within a product development, design transfer and manufacturing environment\nIntermediate Excel capability, for example pivot tables, lookups, conditional formatting and analysis/trending of quality data.\nExperience using digital reporting or data-visualisation tools such as Power BI\nGood problem-solving and analytical skills, with experience supporting investigations and corrective actions.\nIn return you will receive:\nCompetitive salary\nPension Scheme (10% non-contributory)\nPrivate Health Insurance\nPrivate Dental Insurance\nGroup Income Protection\nGroup Life Assurance\n25 days holiday plus UK bank holidays\nHigh Street Discount Scheme.\nApplication is via CV and a one-page covering letter outlining your suitability for the role, salary expectations and notice period.\nPlease note that we will need to establish your right to work during the recruitment process.","description_format":"text","description_chars":4576,"description_truncated":false,"requirements":{"experience_years_min":3,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[]},"benefits":["Dental insurance","Health 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