Quality Assistant

Location:Felgueiras, PT
Job Family: Quality Assurance
Country/Region: Portugal
As the Quality Assistant in our Felgueiras (FEL) site, you are responsible for supporting the quality strategy and quality mindset is implemented on site in FEL, support Operations and the Head of Quality with any quality related task, and support in general with questions related to Quality and Coloplast Quality Management System and Quality Processes.

Major areas of accountability* Ensure Operations support within Quality related topics and challenges

• Ensure compliance with Coloplast Quality Management system.


• Ensure continuous improvement of processes \& specifications.


• Provide sparring and support to Operations in CMPT regarding quality issues and help improve overall quality understanding.


• External / internal Audit support


• Maintain high quality understanding in operations through support and guidance of operators daily

Essential Duties / Responsibilities

• *General:*

+ Monitor compliance with quality assurance tasks performed by operators in Operations
+ Support the management of compliance in Operations (error reports – NCR (registration and initiation))
+ Performance of administrative activities related to archiving, sending samples and if necessary, quarantine of materials within the Felgueiras factory.
+ Handling of inappropriate raw materials in the production area (carrying out control tests, keeping in contact with the Value Stream Manager and Supply Chain if needed).
+ Introduction of quality assurance documents for both production and quality assurance department.
+ Archiving the quality assurance documents and records related to Operations, following the process based on the current instructions.
+ Support involving documents related to Operations by review from Q point of view
+ Support the organizing of sorting, repackaging, rework, preparing reports with supervision
+ Daily tour of the production area to support the reporting non\-conformities and the initiation of immediate action(s)
+ To cooperate with the validation team in the validation of all production assets used in the Value Stream (material handling, support NCR management). Participation in validation runs, support with performing the necessary tests if needed
+ Using an ERP system
+ Preparation of regular QA reports
+ Organizing, conducting and holding regular and ad hoc training on the quality management tasks and the quality management system operating in Value Stream
+ Supporting and replacing the daily work of the quality assurance engineer at regular quality meetings
+ Observing and enforcing work discipline
+ Participation in the investigation of customer complaints, the introduction of preventive and corrective actions

• *Department:*

+ Support Quality Training in FEL Quality.

• *Quality processes:*

+ Capable of Status change in the ERP system
+ NC Action Owner
+ CC Action Owner

+ Support manufacturing related complaint handling in FEL
+ Provide Support towards NCRs on site

Required knowledge, skills \& abilities

Cross\-functional: Self\-management, critical thinking, collaboration \& communication.

• Functional competencies: Coloplast specific knowledge of quality management system and processes.


• Fluent in both spoken and written English

Preferred qualification

• Experience in production with quality focus or quality roles


• Good English skills in verbal and written form


• Structured and systematic


• Conducting own work independently

*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.*

*Visit us on* *Coloplast.com.Watch the film.* *Follow us on* *LinkedIn**.*

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