Global Quality Engineer: QMS, RCA & Compliance

Coloplast; Felgueiras; Vor Ort; EUR 42.000 - 65.000; Vollzeit

Benefits dieser Stelle

Health insurance

Zusammenfassung

Coloplast in Felgueiras, Portugal is seeking a Quality Engineer to support the quality strategy and ensure the Coloplast Quality Management System is applied on site. You will act as a Quality Adviser/Subject Matter Expert, reporting to the Head of Quality and collaborating across functions.

Key responsibilities include managing Change Controls and NCs, leading RCA investigations, reviewing quality documentation, participating in design and product transfers, and supporting audits and continuous

Qualifikationen

• 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.
• Analytical reasoning and structured problem solving.
• International experience or experience working with international companies.

Aufgaben

• Manage and approve Change Controls and 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

Kenntnisse

Quality management

QMS & processes

Regulations & standards

Design control

Stakeholder mgmt

English proficiency

Structured problem solving

Independent work

Academic background

International experience

Ausbildung

Academic background in QA or related field

Jobbeschreibung

Coloplast in Felgueiras, Portugal is seeking a Quality Engineer to support the quality strategy and ensure the Coloplast Quality Management System is applied on site. You will act as a Quality Adviser/Subject Matter Expert, reporting to the Head of Quality and collaborating across functions.

Key responsibilities include managing Change Controls and NCs, leading RCA investigations, reviewing quality documentation, participating in design and product transfers, and supporting audits and continuous