Titel

Quality Management Systems Director


Virksomhed

ArjoHuntleigh AB


Frist

Lukket


Indhold

- Strong QA / QMS leader profile with solid experience from pharma, medical device or food industry

ArjoHuntleigh is dedicated to increasing the quality and efficiency of care through innovative medical devices. ArjoHuntleigh’s vision is to be the World Leader in integrated solutions for the care of people with reduced mobility and related conditions. With 5.500 dedicated employees worldwide and annual turnover exceeding US$ 1 billion, ArjoHuntleigh serves the needs of acute and long-term care in more than 100 countries. ArjoHuntleigh is a part of the GETINGE GROUP, a leading global provider of healthcare solutions.

The company has direct sales organizations in more than 30 countries as well as factories and R&D centers in a handful of locations across the world. The headquarters are located in Malmö, and the commercial organization is split in 4 regions: North America, UK/Ireland, Continental Europe, Asia-Pacific/Middle-East/Africa. Product portfolio encompasses medical equipment and integrated solutions in the product segments: Medical beds, Lifting and Transfers, Hygiene Systems, Therapeutic Surfaces, DVT Prevention, Wound Healing, Disinfection, Diagnostics and Special Solutions (burns treatment and bariatric care).

Headquarters in Malmö employes around 40 eomployees, 4-5 of them in the Global Quality & Regulatory Management department where this newly established position as Quality Management Systems Director is placed. Malmö is also home to a large R&D centre. To further improve quality assurance and quality management - also in recently acquired companies - ArjoHuntleigh is now seeing a strong Quality Management Systems Director with a keen process and change focus. 

T he Quality Management Systems function you will lead corresponds to what is typically labelled as Quality Assurance functions in other medical devices or pharmaceutical companies. It consists of highly skilled and experienced quality management professionals mainly with academic backgrounds. Job roles in the team includes Quality Auditors, CAPA and Software Validation Specialists and a Senior Project Manager. The culture of the team is characterized by professionalism, growth and change in an open atmosphere where colleagues are helpful, have fun and find pragmatic solutions to business needs.

 

Responsibilities
AsQuality Management Systems Director you will be responsible and accountable for establishing, executing and managing the ArjoHuntleigh companywide Quality system according to standards and regulations e.g. QSR, ISO 13485 and MDD and in line with the ArjoHuntleigh company business processes. Your position will have a global scope and is directly managing a team of currently 5 Quality Management professionals mainly in Europe. The position reports to Vice President for Quality & Regulatory Management and you will have interfaces to almost every corner of the ArjoHuntleigh organization.

Each region has Quality Directors and decentralized Quality functions in the supply chain organization and factories. Part of the position will be to lead improvement projects across the organization and implement group quality procedures and thereby accelerate the deployment of the Quality Management System.Key responsibility areas for the position are described below. Some of the tasks are handled by your reports while you also handle some of them yourself which makes the position span from a rather strategic to a more hands-on perspective.

·         Managing the activities in the companywide Quality Management System including internal and external audits and the CAPA process

·         Identify and manage continuous improvement projects

·         Accountable and responsible for the global CAPA process and derived activities

·         Maintenance and improvements of the ArjoHuntleigh global quality management system, CareView

·         Planning and performing global internal quality audits

·         Follow up on findings at internal and external audits or inspections

·         Accountable for quality-related IT validation projects

·         Responsible for management reviews in the operational organizations globally


Expect international travelling on a monthly basis, mainly to ArjoHuntleigh sites in Europe and US.

Candidate Profile

The ideal candidate has an academic background, preferably Engineering, Science or equivalent. An education as Lead Auditor is considered an advantage, but at least you have experience with external auditing, e.g. other companies or suppliers. has minimum 5-7 years of quality compliance experience from the medical device or pharmaceutical industry but may also very well have substantially longer experience than this. Furthermore, you possess the following qualifications and professional competencies:

·       Good knowledge in applicable regulations and standards, e.g. QSR, ISO 13485, CMDCAS, MDD

·       Ability to effectively manage employees and their assigned tasks for accurate and timely completion, including performance management

·       Documented experience in managing a global organization

·       Documented experience within process management

 

Your personality is characterized by strong leadership skills including the ability to set objectives, prioritize activities, create measurement and control systems, and at the same time develop, inspire and motivate people. A structured personality will support you in planning, organizing and executing activities in your team an efficient value adding manner. You must be a self-starter with an execution orientated mindset in order to ensure that new quality initiatives will be implemented. In addition you have a keen process focus and a pragmatic and change orientated mindset enabling you to challenge procedures. Finally, you have the ability to take a holistic view and strategic focus providing you with a good overview of business needs and requirements.

 

ArjoHuntleigh Offers
An interesting and challenging senior Quality Management leadership position in a rapidly growing company with a very low degree of bureaucracy but big on impact. There will be lot of opportunity to further build up and improve quality systems affecting the performance and success of the company. The compensation and benefits package will be on an attractive level. Besides fixed salary it will include
bonus, pension scheme health insurance, possible car allowance etc.


Focus Recruitment
H.C. Ørsteds Vej 50 C, 5.
1879 Frederiksberg C
Tel: +45 70 20 92 15
Mail: info@focus-recruitment.dk