As the Quality Engineer in Quality in Felgueiras, Portugal (FEL), you are responsible for supporting the quality strategy and quality mindset is implemented on site in FEL, support the Head of Quality as well as the site as a Quality Adviser/Subject Matter Expert within, Quality and Coloplast Quality Management System and Quality Processes.

Major areas of accountability

Manage and approve Change Controls and Non-Conformities (NCs).
Support and facilitate Root Cause Analysis (RCA) investigations.
Review and approve quality documentation, risk assessments, and validation protocols (IQ/OQ/PQ).
Participate in design transfers, product transfers, and development projects.
Support manufacturing-related complaint handling and quality investigations.
Maintain quality systems and documentation (QMS, DMR, Control Plans, Records).
Support internal and external audits, as well as international manufacturing sites.
Drive quality improvements and ensure compliance with company and regulatory requirements.
Maintain and Own the Quality Setup for Operations in FEL
Ensure compliance with Coloplast Quality Management system and continuous improvement of processes & specifications.
Provide sparring and support to functions in CMPT and International Manufacturing Sites regarding quality issues and help improve the overall quality understanding
Support training and development of CMPT in the Quality Processes

Required knowledge, skills & abilities

Cross-functional: business & value chain understanding, self-management, decision-making and critical thinking, collaboration & communication.

Experience in Quality Management
QMS and Quality Processes
Regulations & Standards
Design control & Validation
Experience with internal and external stakeholder management
Good English skills in verbal and written form
Structured and systematic
Conducting own work independently
Relevant academic background; analytical reasoning, structured problem solving and strong methodological approach
International experience or experience working with international companies

Physical or other job requirements

Mobile; estimated travel in position up to 20 travel days a year

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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Quality Engineer

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