QA Specialist for Pilot Plant

Would you like to provide quality assurance to help one of the best-performing medical device companies in the world to ensure product quality globally?

If so, join a highly engaged team operating in a dynamic and professionally challenging working environment, where you will have the opportunity to grow and expand these skills even further collaborating with a large network of stakeholders and ensuring that our QA deliveries meets applicable requirements.

Operation and innovation projects
As part of the Quality department, you will be based in our Pilot Plant located in Mørdrup, 40 kilometers north of Copenhagen. Working alongside 15 dedicated colleagues in Quality, you will be one of the 6 QA specialists involved in our Supply value stream and Innovation value stream at Pilot Plant.

Your role involves a high degree of cross-organizational collaboration and you can expect up to 20 days of international travel per year. In addition to working closely with your colleagues in the both operation - and project teams, you will have a close link to R&D functions, as well as the Global QA, RA & Sustainability organization in Headquarter/Humlebæk. 

You will collaborate with the International Manufacturing Sites located in Hungary, China, and Costa Rica, providing QA support to our colleagues ensuring that quality is in place. 

Ensure compliance with Coloplast Quality Management system
Your main task is to support operations and ensure a compliant QA set-up is used for production. You will also be involved in projects collaborating with a large network of stakeholders and ensuring that our QA project deliveries meets applicable requirements. You deliver high quality at a high pace.

Specifically, you:

• Create and maintain Quality set-up (Control Plan, Quality Plan/DMR, quality records etc.)
• Deliver inputs from a quality and production perspective in product development projects
• Handle change requests to continuously improve quality of our processes and products.
• Handle, creation, disposition, approval, and closure of non-conformity reports.
• Participate in internal/external audits.

In order to secure alignment in our processes and project deliverables, you promote and facilitate knowledge sharing and collaboration in the QA team. In projects, you will give relevant QA inputs during the design phase and ensure that the Pilot Plant QA deliverables are timely and qualified. Time to market is crucial, so you deliver high quality at a high pace.

Specifically, you:

• Deliver inputs from a production perspective of the quality part of the product development phase, specifically design specifications and product risk assessment documentation
• Review and approve process risk assessment and process validation documentation in development projects and operations. 
• Support operation while running production at Pilot Plant
• Participate in transfer tasks delivering support to International Manufacturing sites regarding quality related activities including internal audit if required
• Handle change requests and CAPA´s including facilitation of RCA events in order to continuously improve quality of our processes and products
• Handle disposition, approval and closure of non-conformity reports
• Participate in internal/external audits

Strong stakeholder management skills and drive
In this role, excellent communication and stakeholder management skills are vital. On a personal level, you are highly driven and know how to take ownership of your tasks and push an idea through.  Your sense of humor and ability to listen makes you a good team player, and you enjoy collaborating and sharing knowledge with your colleagues. Project work and collaboration in an international organization suits you well, because you appreciate the dynamics of a fast-paced and changeable work environment.

Furtheremore you: 

• Hold a BSc or MSc in pharmacy, engineering or a related field.
• Have quality experience within the medical device or pharmaceutical industry, including ISO9001/13485 & GMP.
• Have experience within process validation and quality assurance - being a part of setting up robust quality processes in pilot production, ensuring smooth transfer to volume production.
• Take an analytical approach to the assessment of corrective and preventive actions conducted in a NC or CAPA process.
• It would be an advantage if you have experience being in the auditee role, being audited by authorities or internal colleagues.

Interested? 
If you would like to know more about the position, please write to Head of Pilot QA, Rikke Christensen by mail: dkrla@coloplast.com. We will take candidates into the recruitment process continuously, so do not hesitate to apply. This position will remain open until a suitable candidate has been found.

Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 14.000 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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