Trabajo en Østsjælland (Dinamarca) de ingeniero de control de calidad/ingeniera de control de calidad

 Quality Engineers for Convatec Infusion Care

Are you passionate about driving Quality? Do you want to join a world leading company specialized in treatment of chronic diseases such as Diabetes and Parkinson’s Disease? Then you might be one of the right candidates to join the quality organization as a Quality Engineer – as we are looking for 2 candidates.

Convatec Infusion Care is transforming their business for the better. Better products. Higher quality. Better ways of working. Join them on this transformative journey as their new Quality Engineer and help shape the future of the company and their patients.

About The Role

As their new Quality Engineer, you will have a broad interaction with the organization and work within areas such as risk management, process validations, handling of non-conforming products, just to name a few. As a part of the Quality Engineering team, you will also take part in other activities needed to maintain the right level of compliance in order to meet the expectations of their customers and relevant authorities.

You will be part of a highly engaged team, where collaboration and a positive can-do attitude is highly valued. You will report to the Quality Engineering Manager and your main work location will be in Osted (south of Roskilde, Denmark), where most of the local quality department is located – or alternatively in the office in Søborg. Flexibility to work from home several days per week is offered. You can expect up to 15 travel days annually mainly to the manufacturing sites in Mexico.

Your key responsibilities

• Understand and review process and software validation documentation, change request, design and process FMEA’s.
• Provide Quality Engineering support to R&D and Sustaining Engineering department and provide review of associated documentation. 
• Provide input and support to Corrective and Preventive Action (CAPA) and Non-Conforming product process. 
• Support External audit programs. 
• Conduct risk assessments. 
• Initiate, manage and execute projects for continuous improvement projects within department and participate in cross organizational projects. 
• Ensure efficient and operational systems and procedures and alignment with our manufacturing sites in Reynosa (Mexico).

Your competencies

• You have the ability to think in a clear, decisive manner, remaining calm under stressful and challenging conditions.
• You have a structured approach to tasks and challenges.
• You have the ability to work in teams and have a solution driven mindset.

Qualifications

 To succeed in this role, you have:

• A master’s or bachelor’s degree in engineering, chemistry, biology, pharmacy or similar. You can also have a relevant technical degree.
• Experience in Quality Management and the application of ISO 13485 and FDS 21 CFR part 820 in a medical device industry. 
• Sufficient experienced gained in Quality Engineering environment to demonstrate a thorough understanding of a risk-based quality approach. 
• Experience in validation executions e.g., IQ, OQ, PQ and DoE. 
• Experience in using statistical software as SAS JMP. 
• Experience in implementing use of SPS, process capability and Quality tools. 
• Experience with QMS, NC/CAPA and Change Control Systems.
• Proficiency in English verbal and written.

About You

We are looking for a candidate experienced within Quality Engineering. You are a team player, and you thrive in an international matrix organization characterized by cross-functional teamwork. You are pragmatic and operate with a sense of urgency to meet your deadlines. You enjoy a busy working day and can progress several tasks in parallel. You have proven analytical and problem-solving skills that will help you to take fast and well-founded decisions.

About Convatec

We offer you a position in a dynamic and global company where the days are never the same. Convatec will provide you with challenges and development opportunities and the chance to influence your own role from day one. You will be a part of a great community where everyone helps and support each other – while continuously building on their competences and network.

Interviews will be conducted continuously, so we encourage you to submit your application as soon as possible. 

At Convatec, their vision is pioneering trusted medical solutions to improve the lives they touch. They devise, develop, and manufacture innovative products and services that support people with deeply personal and challenging medical conditions, helping to improve care for them and giving them greater confidence, freedom, and mobility. 

Convatec, Infusion Care (Unomedical a/s) is a part of a global medical technology business focused on serving people and care givers. They develop and market sterile disposable products for subcutaneous infusion of various medications. Specialized in the treatment of chronic diseases, such as Diabetes Mellitus and Parkinson’s Disease. Their manufacturing facilities in Denmark and Mexico produce more than 100 million infusion sets per year, making them the world leader within this field. 

Further information about the company can be found at their website www.b2b.convatec.com or www.convatec.com.

Equal opportunities 

Convatec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.