BEMÆRK: Ansøgningsfristen er overskredet
QMS Manager for Convatec Infusion Care
Are you passionate about leading people and driving Quality Management Systems in a Quality Assurance 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 Management System Manager (QMS 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 QMS Manager and help shape the future of the company and their patients.
About the role
As their new QMS Manager, you will be leading a team responsible for timely deliveries according to the quality and compliance plans. We are looking for an experienced QMS Manager to lead and develop the team and bring focus to deliverables and KPI’s.
The QMS Manager is responsible for delivering an effective, efficient, and proactive Quality Management System to enable business success. You will be responsible for their Quality Management System (ISO13485 and MDSAP-certified), Change Control System, Non-Conformance and CAPA system for Convatec Infusion Care, site Osted.
They are on a journey improving their quality processes and just implemented a new QMS. This position provides a unique opportunity to impact their quality processes and the business impacting all Convatec.
You will report to the Site Quality Director and your main work location will be in Denmark Osted (south of Roskilde), where most of the local quality department is located. Flexibility to work from home several days per week is offered.
Your key responsibilities
Main responsibilities in this role include - but is not limited to:
- Leading the QMS team for Convatec Infusion Care, site Osted
- Bring structure and motivation and facilitate cross-functional teamwork
- Ensure efficient and operational systems and procedures and alignment with the manufacturing sites in Mexico
- Ensure quality awareness around the organization with focus on NC/CAPA and Change Control
- Support oversight of the Non-Conformance (NC) and Corrective Action/Preventive Action (CAPA) system
- Ensure compliance to FDA 21 CFR Part 820, ISO 13485:2016, Medical Device Single Audit Program, and other applicable global Quality System Regulations
- Owning and overseeing the global NC/CAPA process including monitoring process performance and implementing continuous process improvement
- Strategic driver for a world class Non-conformance/CAPA process
- Establish and maintain a productive relation with the relevant stakeholders based on trust and respect
- Reporting KPI status on a monthly basis (or as needed) to Leadership Teams
- Supporting the global quality team with creation, consolidation, and simplification of strategies and company quality programs/projects
Non-conformance & CAPA process management
- Lead site NC/CAPA continuous improvement workshops
- Develop and provide general training to the global and site NC/CAPA team and other applicable users as necessary. Facilitate training when changes are made to the process
- Participate as a NC/CAPA subject matter expert during internal and external audits
- Lead process performance review meetings with the global NC/CAPA team
- Lead site CAPA Review Board meetings
General Quality Management System support
- Assist in the preparation and execution of site Management Review meetings
- Participate as a site internal auditor if competency requirements are satisfied
- Maintain strong knowledge of medical device standards/regulations
- Act as delegate of Site Quality Director
Besides having a proven track record as a people leader and Quality Assurance 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.
To succeed in this role, you:
- Have proven leadership experience successfully leading teams
- Hold an MSc or BSc in Engineering, Chemistry, Biology, Pharmacy or similar
- Have experience in Medical Device Quality Assurance (Class II or higher)
- Have experience with QMS, NC/CAPA and Change Control Systems
- Have extensive experience with audit documentation
- Have extensive experience training/guiding on root cause investigation and technical writing
- Have experience in standards and regulations within the Medical Device Industry (ISO13485: 2016, MDSAP, CFR 820)
- Are proficiency in English verbal and written
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.
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.
INFORMATIONER OM STILLINGEN:
- Arbejdspladsen ligger i:
SCANPEOPLE ApS, Roskildevej, 2630 Taastrup
Ansøgningsfrist: 22-01-2024; - ansøgningsfristen er overskredet
Se mere her: https://job.jobnet.dk/CV/FindWork/Details/5948194