- Coordinate 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.
- Ensure affected product, materials, equipment and processes are correctly identified, segregated, documented and escalated in accordance with approved procedures.
- Coordinate operational inputs for investigations, including fact collection, defect characterization, traceability, impact assessment and evidence gathering.
- Facilitate structured root cause analysis with Production, Quality, Engineering and other relevant functions, translating confirmed causes into proportionate corrective and preventive actions.
- Monitor open non-conformities and CAPAs, priorities, ageing, implementation status, due dates and effectiveness checks, escalating risks and overdue actions.
- Ensure decisions, actions and supporting evidence are documented clearly, accurately and in a timely manner.
- Assess the applicability of non-conformities, CAPAs and lessons learned across equivalent machines, processes, shifts and value streams.
- Coordinate transversal implementation of approved containment, corrective and preventive measures, avoiding isolated local solutions.
- Harmonize operational quality documentation, inspection routines, defect catalogues, escalation criteria and related standards together with process owners.
- Ensure approved changes are reflected in applicable work instructions, forms, training content and shop floor routines.
- Lead and coordinate approximately 10 to 15 Inspection Operators assigned across the value streams.
- Define daily priorities and allocate Inspection Operators according to production needs, quality risk, workload and competence requirements.
- Ensure consistent inspection practices, decision criteria, documentation and escalation routines across shifts and production areas.
- Coach team members, provide regular feedback and support competence development, qualification, multiskilling and succession planning.
- Contribute to recruitment, onboarding, performance follow-up, attendance management and development planning for the team.
- Identify trends and recurring issues and translate data into focused improvement priorities.
- Coordinate routine NC and CAPA reviews with Production, Quality and support functions.
- Support audits, inspections, management reviews and regulatory requests by ensuring records are complete, traceable and available.
- Contribute to change control, validation, risk management and continuous improvement activities when operational input is required.
- Act as a role model for quality, safety, compliance, leadership behaviour and Coloplast values.
- Perform any additional tasks assigned by the direct leader as part of the role.
Essential Qualifications:
- Higher education degree in Quality, Engineering, Life Sciences, Industrial Management or another relevant field.
- Professional experience in Quality, manufacturing quality, non-conformity management, CAPA, quality assurance or a related operational quality role.
- Practical experience with containment, investigation, root cause analysis, corrective-action follow-up and effectiveness verification.
- Experience leading a team or demonstrating clear readiness for first-line people leadership.
- Good command of English and Portuguese, written and spoken.
- Good Microsoft Office skills, particularly Excel, Word and PowerPoint.
- Ability to work primarily on site and provide support across operating shifts when business needs require it.
Preferred Qualifications:
- Experience in the medical-device, pharmaceutical or another regulated manufacturing industry.
- Training in structured problem solving, root cause analysis, Lean Manufacturing or continuous improvement.
- Previous experience leading an operational quality team.
Required Knowledge, Skills, and Abilities:
- Strong quality mindset and attention to detail, with the ability to maintain accuracy under operational pressure.
- Structured problem-solving and analytical capability, including trend analysis and evidence-based decision-making.
- Strong document-management discipline and ability to write clear, concise and traceable quality records.
- Ability to coordinate cross-functional stakeholders and drive actions to completion while maintaining clear accountability.
- People leadership, coaching, feedback and workload-prioritization skills.
- Clear communication, constructive challenge and confident escalation of quality or compliance risks.
- Ability to balance shop floor responsiveness with rigorous compliance and documentation requirements.
- Ability to identify systemic risk and ensure transversal implementation across comparable processes and equipment.
- High integrity, ownership, confidentiality and customer focus.
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