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.
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.