QC Manager. Østsjælland. Dinamarca

 QC Manager for Convatec Infusion Care

Are you passionate about leading people in a Quality Control department to success? 

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 the right candidate to join the quality organization as a Quality Control Manager (QC Manager).

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 QC Manager and help shape the future of the company and their patients.

About the role

As their new QC Manager, you will report directly to the Site Quality Director, and you will have the authority to sign for her, when she is on vacation and at emergency situations. You will be responsible for the coordination of work tasks in the QC Team and ensuring that the requirements of both national and international standards and regulations are met.

Your main work location will be in Osted (south of Roskilde, Denmark), where most of the local quality department is located. Flexibility to work from home several days per week is offered.

Team responsibilities

• Release of incoming and outgoing controls are carried out uniformly by impartial staff with direct reference.
• Deviating products are identified and processed according to applicable procedure.
• The traceability and maintenance of batch documentation is maintained in relation to incoming and outgoing controls.
• Archiving is maintained so that all batch documentation can easily be found in the archives.
• Support in SCAR-handling.
• Testing of complaints is a high priority and thus contributes to a quick response to the customer.
• Participate in projects where quality aspects must be elucidated using the QC Team skills.

Your internal responsibilities

• Pointed as person responsible for regulatory compliance (PRRC) is reiterated subsequently in MDR 745/2017 article 15 section 3.a).
• Responsible for the conformity of medical devise is checked in accordance with the QMS (before delivery) (MDR 745/2017 Article 10 (9)).
• To participate in the daily planning of the control groups’ tasks.
• To carry out incoming and outgoing control in accordance with applicable specifications.
• Making feedback in the ERP.
• To distribute/replace controlled documents in production according to the applicable document distribution list.
• To participate in the training of new QC Assistants in incoming- and outgoing control.
• To test used and unused products in connection with customer complaints.
• To archive the production and QC Teams batch documentation.
• Contributing to work routines being continuously assessed and improved.
• Contributing to the control group maintaining flexibility by including more people in some of the group’s work areas, so that the work areas are not vulnerable to manpower loss.
• To participate in projects where quality aspects must be elucidated, after coordination and acceptance by immediate superiors.
• To participate in audits and carrying out supplier audits.

Your external responsibilities

• To involve immediate superiors in problems in relation to planning, training, resources, quality issues etc.
• To involve the Metrology Technician in case of problems and/or doubts about measuring equipment and measurement methods.
• To make the nearest superior and the Metrology Technician aware of inconsistencies in relation to documents and specifications, so that they can be rectified as soon as possible by the person responsible for the area.
• To coordinate with the Warehouse Coordinator regarding any prioritization for incoming controls.
• To coordinate with immediate superiors and the production’s Q-responsible in the event of a detected deviation on products and raw materials.
• To inform Logistics as soon as possible in case of detected deviations in incoming control.
• To receive and, if necessary, pass on necessary information to the QC Team.
• To receive teaching/training according to individual education plans and possibly other educational activities.

Your competencies

• You are able to dispose of deviations for incoming and outgoing controls within the applicable framework.
• You are able to carry out final release of incoming- and outgoing controls.
• You are able to call the immediate superior to a meeting regarding the solution of any quality problems.
• You are able to coordinate directly with warehouse coordinator/manager regarding the prioritization of incoming- and outgoing controls.
• You are able to make final release of sterilized products. 

About you

Besides having a proven track record as a people leader and Quality Control experience, you are a team player with a holistic mindset, and you thrive in an international matrix organization characterised by cross-functional teamwork. To lead and steer the team safely and with motivation and good spirit, you also bring good collaborations skills, when working with other functions in Convatec Infusion Care in both Denmark and Mexico.

You apply best practices and facilitate the development of efficient, effective, and fully compliant processes that meet the requirements of all global regulations and deliver quantifiable savings from process efficiency. 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.

Qualifications

To succeed in this role, you:

• Have proven leadership experience successfully leading teams.
• Hold an MSc or BSc in Engineering, Chemistry, Biology, Pharmacy or a relevant technical degree.
• Have a minimum of 4 years of experience in regulatory affairs or in quality management systems relating to medical devices.
• You possess knowledge of basic requirements in the FDA’s QSR, GMP and ISO 13485 or similar.
• You possess knowledge of ISO 9001 as a lead auditor.
• Are proficient in English verbal and written.

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 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.