Process Control Specialist

Coloplast; Viseu; On-site; EUR 42,000 - 60,000; Full time

Job summary

Coloplast is seeking a Process Control Specialist in Portugal to coordinate quality activities across value streams, manage CAPA records, and lead a team ofInspection Operators. You will ensure containment, investigations, and effective corrective actions aligned with Coloplast standards.

You will drive structured root cause analysis with cross-functional partners and maintain rigorous documentation, while supporting audits and change control.

Qualifications

• Higher education in Quality, Engineering, Life Sciences, Industrial Management or related field.
• Experience in quality, manufacturing quality, non-conformity management and CAPA.
• Experience with containment, investigation, root cause analysis and follow-up.
• Experience leading a team or readiness for first-line leadership.
• Fluent English and Portuguese, written and spoken.
• Proficient MS Office skills (Excel, Word, PowerPoint).
• On-site work availability with shift support as needed.

Responsibilities

• Coordinate end-to-end workflow for non-conformities and CAPA records from detection to closure.
• Identify and escalate affected product, materials, equipment and processes.
• Gather evidence for investigations and support root cause analysis with cross-functional teams.
• Translate causes into corrective and preventive actions and verify effectiveness.
• Monitor CAPAs, aging, due dates and escalation of risks and overdue actions.
• Document decisions, actions and evidence clearly and promptly.
• Coordinate containment, investigations and lessons learned across similar processes.
• Harmonize quality documentation, inspection routines and standards with process owners.
• Lead 10–15 Inspection Operators across value streams and assign daily priorities.
• Support audits, inspections and regulatory requests with complete traceable records.
• Participate in change control, validation, risk management and continuous improvement.
• Model Coloplast values and provide coaching, feedback and development planning.

Skills

CAPA management

Non-conformity handling

Root cause analysis

Quality improvement

Team leadership

Cross-functional collaboration

Documentation & record keeping

Education

Higher education degree in Quality, Engineering, Life Sciences, Industrial Management

Tools

Excel

Word

PowerPoint

Job description

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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.

Major Areas of Accountability:

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.

Pursuing 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.

Coloplast 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.

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