{"id":2268722,"url":"https://alion.io/job/coloplast-process-control-specialist","title":"Process Control Specialist","company":{"id":13696,"name":"Coloplast","domain":"coloplast.com","url":"https://alion.io/company/coloplast","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"SuccessFactors","truth_index":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":null,"employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Felgueiras, Portugal"],"countries":["PT"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":28000,"max_usd":77000,"period":"year","method":"role_country_seniority_unknown","sample_n":36},"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"Mandiant capa","optional":false},{"name":"Microsoft Office","optional":false}],"status":"live","first_seen_at":"2026-10-02T00:00:00Z","employer_posted_date":"2026-10-02","last_verified_at":"2026-10-24T03:56:47Z","board_verified":true,"closed_at":null,"days_open":22,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":22},"description":"Coordinate quality activities across the value streams, managing product and process non-conformities and CAPA. Ensure timely containment, investigation, documentation, action follow-up, effectiveness checks, and implementation of corrective and preventive actions across the organization. Lead and develop a team of 10 to 15 Inspection Operators and serve as the key link between Production, Quality, Engineering, and other support functions.\n\nMajor Areas of Accountability:\n\nCoordinate the end-to-end operational workflow for product and process non-conformities and related CAPA records, from detection and immediate containment through investigation, action definition, implementation, effectiveness verification and closure. \nEnsure affected product, materials, equipment and processes are correctly identified, segregated, documented and escalated in accordance with approved procedures. \nCoordinate operational inputs for investigations, including fact collection, defect characterization, traceability, impact assessment and evidence gathering. \nFacilitate structured root cause analysis with Production, Quality, Engineering and other relevant functions, translating confirmed causes into proportionate corrective and preventive actions. \nMonitor open non-conformities and CAPAs, priorities, ageing, implementation status, due dates and effectiveness checks, escalating risks and overdue actions. \nEnsure decisions, actions and supporting evidence are documented clearly, accurately and in a timely manner. \nAssess the applicability of non-conformities, CAPAs and lessons learned across equivalent machines, processes, shifts and value streams. \nCoordinate transversal implementation of approved containment, corrective and preventive measures, avoiding isolated local solutions. \nHarmonize operational quality documentation, inspection routines, defect catalogues, escalation criteria and related standards together with process owners. \nEnsure approved changes are reflected in applicable work instructions, forms, training content and shop floor routines. \nLead and coordinate approximately 10 to 15 Inspection Operators assigned across the value streams. \nDefine daily priorities and allocate Inspection Operators according to production needs, quality risk, workload and competence requirements. \nEnsure consistent inspection practices, decision criteria, documentation and escalation routines across shifts and production areas. \nCoach team members, provide regular feedback and support competence development, qualification, multiskilling and succession planning. \nContribute to recruitment, onboarding, performance follow-up, attendance management and development planning for the team. \nIdentify trends and recurring issues and translate data into focused improvement priorities. \nCoordinate routine NC and CAPA reviews with Production, Quality and support functions. \nSupport audits, inspections, management reviews and regulatory requests by ensuring records are complete, traceable and available. \nContribute to change control, validation, risk management and continuous improvement activities when operational input is required. \nAct as a role model for quality, safety, compliance, leadership behaviour and Coloplast values. \nPerform any additional tasks assigned by the direct leader as part of the role.\nEssential Qualifications:\nHigher education degree in Quality, Engineering, Life Sciences, Industrial Management or another relevant field.\nProfessional experience in Quality, manufacturing quality, non-conformity management, CAPA, quality assurance or a related operational quality role.\nPractical experience with containment, investigation, root cause analysis, corrective-action follow-up and effectiveness verification.\nExperience leading a team or demonstrating clear readiness for first-line people leadership.\nGood command of English and Portuguese, written and spoken.\nGood Microsoft Office skills, particularly Excel, Word and PowerPoint.\nAbility to work primarily on site and provide support across operating shifts when business needs require it.\nPreferred Qualifications:\nExperience in the medical-device, pharmaceutical or another regulated manufacturing industry.\nTraining in structured problem solving, root cause analysis, Lean Manufacturing or continuous improvement.\nPrevious experience leading an operational quality team.\nRequired Knowledge, Skills, and Abilities:\nStrong quality mindset and attention to detail, with the ability to maintain accuracy under operational pressure.\nStructured problem-solving and analytical capability, including trend analysis and evidence-based decision-making.\nStrong document-management discipline and ability to write clear, concise and traceable quality records.\nAbility to coordinate cross-functional stakeholders and drive actions to completion while maintaining clear accountability.\nPeople leadership, coaching, feedback and workload-prioritization skills.\nClear communication, constructive challenge and confident escalation of quality or compliance risks.\nAbility to balance shop floor responsiveness with rigorous compliance and documentation requirements.\nAbility to identify systemic risk and ensure transversal implementation across comparable processes and equipment.\nHigh integrity, ownership, confidentiality and customer focus.\n\nPursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 16.000 people and with products available in more than 143 countries, we are one of the world´s leading medical device companies. We are constantly growing our business and always looking for new ways to move forward - we explore, learn and look for new ways of doing things. \nColoplast is committed to being an inclusive organization, where people bring their differences to work each day, fulfil their potential and have a strong sense of belonging because - and not despite - of their differences. We therefore encourage all qualified candidates to apply regardless of gender, age, race, nationality, ethnicity, sexual orientation, religious belief or physical ability. \nVisit us on Coloplast.com. \nWatch the film. Follow us on LinkedIn.\n62225","description_format":"text","description_chars":6244,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":10,"manages_managers":false,"education":null,"security_clearance":false,"languages":[{"language":"Portuguese","level":"All levels","optional":false},{"language":"English","level":"All levels","optional":false}]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Chemical Engineering","Medical Supplies & Consumables","Wound Care"],"lifecycle":[{"event":"open","at":"2026-10-11T07:19:24Z"}],"visa":[],"liveness":{"score":37,"band":"fade","label":"Fading","p_open":1,"p_active":0.665,"p_room":0.55,"age_days":22,"expected_fill_days":20,"reasons":["conf:2","velocity","win:tail","comp:brand"],"computed_at":"2026-10-24T06:02:35Z"},"pay":null,"html_url":"https://alion.io/job/coloplast-process-control-specialist","json_url":"https://alion.io/job/coloplast-process-control-specialist.json","meta":{"generated_at":"2026-10-24T10:52:55Z","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":15481,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-25T00:00:00Z"}},"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":13696},"rest":"https://alion.io/mcp/rest/get_company?id=13696"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fcoloplast-process-control-specialist"},{"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%2Fcoloplast-process-control-specialist"},{"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%2Fcoloplast-process-control-specialist"},{"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/coloplast-process-control-specialist\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fcoloplast-process-control-specialist"}]}