QA specialist for Pilot Plant
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Espergærde
Join a highly engaged team operating in a dynamic and professionally challenging working environment.
As a QA specialist, you help create new innovative medico products that help people with intimate healthcare needs. Working on projects from the initial design phase through to manufacturing, you get to oversee every step of the way, collaborating with a large network of stakeholders and ensuring that our QA project deliveries meets applicable requirements.
Projects and process alignment
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 5 QA specialists involved in the development of new products in our Pilot production.
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 project teams, you will have a close link to R&D functions, as well as the Global Quality& Regulatory Affairs organization in Headquarter/Humlebæk.
You will collaborate with the international manufacturing sites located in Hungary, China and Costa Rica, providing QA training to our colleagues in manufacturing to ensure that the QA set-up is in place when new product goes into volume production.
Ensure compliance with Coloplast Quality Management system
Your main task is to translate requirements from the design input/output into an efficient and compliant QA set-up in production. 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:
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.
Interested?
At Coloplast, we make sure that you can be you. That is why we encourage applications from suitably qualified and eligible candidates regardless of sex, race, ethnicity, disability, age, sexual orientation, gender reassignment, religion or belief or marital status.
If you would like to know more about the position, please contact Head of Pilot QA, Rikke Christensen by mail: [email protected] or phone: +45 4911 1633. We will take candidates into the recruitment process continuously, so do not hesitate to apply. This position will remain open until 1st of May 2020 at the latest.
Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with very private and personal medical conditions. Employing more than 12,000 people and with products available in more than 140 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. Curiosity works here.
Visit us on Coloplast.com. Follow us on LinkedIn. Like us on Facebook.
As a QA specialist, you help create new innovative medico products that help people with intimate healthcare needs. Working on projects from the initial design phase through to manufacturing, you get to oversee every step of the way, collaborating with a large network of stakeholders and ensuring that our QA project deliveries meets applicable requirements.
Projects and process alignment
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 5 QA specialists involved in the development of new products in our Pilot production.
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 project teams, you will have a close link to R&D functions, as well as the Global Quality& Regulatory Affairs organization in Headquarter/Humlebæk.
You will collaborate with the international manufacturing sites located in Hungary, China and Costa Rica, providing QA training to our colleagues in manufacturing to ensure that the QA set-up is in place when new product goes into volume production.
Ensure compliance with Coloplast Quality Management system
Your main task is to translate requirements from the design input/output into an efficient and compliant QA set-up in production. 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
- Participate in process validations, review and approve Process Risk Assessment and process validation documentation
- Create and maintain Quality set-up (Quality- and Control Plan, DMR index etc.) in development projects and operations
- 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 creation, 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.
- You hold a BSc or MSc in pharmacy, engineering or a related field
- You have quality experience within the medical device or pharmaceutical industry, including ISO9001/13485 & GMP
- You have experience within process validation and quality assurance – preferably within development projects, being a part of setting up robust quality processes in pilot production, ensuring smooth transfer to volume production
- You 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?
At Coloplast, we make sure that you can be you. That is why we encourage applications from suitably qualified and eligible candidates regardless of sex, race, ethnicity, disability, age, sexual orientation, gender reassignment, religion or belief or marital status.
If you would like to know more about the position, please contact Head of Pilot QA, Rikke Christensen by mail: [email protected] or phone: +45 4911 1633. We will take candidates into the recruitment process continuously, so do not hesitate to apply. This position will remain open until 1st of May 2020 at the latest.
Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with very private and personal medical conditions. Employing more than 12,000 people and with products available in more than 140 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. Curiosity works here.
Visit us on Coloplast.com. Follow us on LinkedIn. Like us on Facebook.
Information og data
Denne ledige stilling har jobtypen "Produktspecialist", og befinder sig i kategorien "Kommunikation, marketing, salg".
Arbejdsstedet er beliggende i Espergærde.
Jobbet er oprettet på vores service den 26.5.2020, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Produktspecialist
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