Quality Assurance Specialist

Coloplast GmbH; Felgueiras; Hybrid; EUR 42,000 - 66,000; Full time

Job summary

Coloplast in Portugal seeks a QA Specialist to lead the quality culture on site in Felgueiras. You will anchor quality mindset across production and serve as a go-to for quality decisions along the value chain.

You will drive design transfer, risk management and CAPA processes while supporting production to meet quality targets and maintain GDP/GMP standards in a cleanroom environment. Fluent English required.

Qualifications

• Minimum 3 years as a QA Specialist/Engineer in production
• Solid understanding of GDP and GMP
• Experience with quality projects is a plus
• Background in production in a cleanroom environment is a plus
• Fluent in spoken and written English

Responsibilities

• Build and maintain a quality culture for the site
• Be Local Process Owner for Corporate Processes (Design Transfer, Risk Management)
• Be the Quality PM in Machine Transfer Program
• Approve Nonconformities, CAPAs, Change Control
• Train and guide the organization on site within quality
• Support production towards quality targets
• Support local quality setup for production

Skills

QA experience

Project management

GDP/GMP knowledge

End-to-End production

English language

Education

B.Sc. or higher

Job description

Select how often (in days) to receive an alert:

Job Family: Quality Assurance

Country/Region: Portugal

Do you want to join the continued development of the new manufacturing for our Continence Care segment within Coloplast?

Be a service partner for/and support the production process, from a quality function, to produce the products our users’ needs in the quality needed?

Then look at this position: QA Specialist

Here you will play a key role in the quality of the products produced as a daily service partner in production. You will play a pivotal role in anchoring, the quality mindset and culture defined, in all mindsets at the production. This role will also be a go-to for production for guidance in relation decisions on product quality in the full value chain on site.

What You will Do:

• Build and maintain a quality culture for the whole site
• Be a Local Process Owner for Corporate Processes, i.e. Design Transfer, Risk Management, etc.
• Be the Quality PM in our Machine Transfer Program
• Be the approver of Nonconformities, CAPAs, Change Control etc.
• Train, instruct and guide the organization on site within quality
• Support production – Partner towards production for quality targes
• Support the local quality setup for production

Your Qualifications:

• Academic background: A relevant academic background (B.Sc. or higher).
• Experience:
• Minimum 3 years as a QA Specialist / Engineer or similar within a production environment combined with Project Management experience
• Solid understanding within the field of Quality i.e. GDP and GMP etc. (Quality Assurance experience is a plus)
• General project knowledge and experience (Quality project management is a plus)
• Knowledge of production in a cleanroom environment is a plus
• Business understanding: Holistic understanding of End-To-End production
• Language Proficiency: Fluent in spoken and written English (other languages are a plus).

Timing:

• Expected start is April 1st, 2027.
• Workplace will be Felgueiras in Portugal
• Occasional travel can be expected

If you have questions about this job opportunity do not hesitate and contact Aslak S. Søgaard – Head of Quality

If you are curious like we are, and want to know more about our company go to http://www.cpbc.pl
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 .

Coloplast Group - Holtedam 1 - Humlebaek - DK 3050 - Denmark