About SHL Group
Established in 1989, SHL Group is a world-leading solution provider in the design, development and manufacturing of advanced drug delivery systems such as auto injectors. With several distinct group companies, our product line ranges from injectors to pressure mattress systems, to laboratory handling equipment to neurosurgical devices.

SHL Healthcare operates as contract developer and contract manufacturer of equipment solutions for home, hospital, and long-term care use with a focus on patient comfort and functionality. SHL Healthcare's main production and development site is in China, where we have close to 250 employees. At SHL Healthcare AB's head office in Nacka Strand, we have 10 employees.

SHL Healthcare
SHL Healthcare is one of the world’s leading providers of equipment solutions for home, hospital, and long-term care use. Together with our customer base we offer development and manufacturing of a broad range of equipment solutions that focus on patient comfort and functionality, including patient repositioning slings, patient transfer products, dynamic mattress systems, and accessories for static and mobile hoist systems.
With a strong project management team, we excel in translating ideas and integrating specifications into customized products. We invest in regulatory surveillance and market reports from which needs and requirements are analyzed and incorporated into the products and technology we develop.
Committed to supplying high-quality healthcare products to our customer base, we utilize a comprehensive range of development and manufacturing resources and skilled workforce in Asia. With an ISO 13485 certification of our design and manufacture of healthcare products, we practice extensive quality control throughout the production process.
For more information about SHL Group and SHL Healthcare, visit http://www.shl-group.com

 

Chief of Quality and Regulatory Officer, SHL Healthcare

Duktig ledare till svenskt MedTech bolag med internationellt fokus i en spännande utvecklingsfas

Chief of Quality & Regulatory Officer, SHL Healthcare

Reporting: CEO, SHL Healthcare (based in Nacka Strand)

Management team membership: Member of the SHL Healthcare management team

Location: SHL Healthcare, Nacka Strand

SHL Healthcare is growing with an increased demand from the market for our services for broad range of developed top-quality equipment solutions for home, hospital and long-term care use. There are currently several global medical devices companies on the client list with a clear potential for future growth and expansion.

To meet those opportunities SHL Healthcare is currently strengthening the organization by adding more key resources to the team in Nacka Strand.

SHL Healthcare offers you a varied and challenging job in a global organization where we together develop and manufactures high quality equipment solutions for home, hospital, and long-term care use. Our customer relations are long-term, and we will have a long-term value creating relation to you as employee. Your personal development in the job is crucial as well as well-being and to have fun together.

We are now recruiting a
Chief of Quality & Regulatory officer (CQRO) to lead, manage and develop the global quality assurance/quality control and regulatory department located in Nacka Strand and at the development and manufacturing site in China. This is a key leadership position focusing on quality assurance, quality control, regulatory affairs and compliance.

The CQRO is broad with a mixture of strategic and operational responsibilities and day-to-day tasks to be covered in a mid-size and growing company. The position includes customer contacts, leadership, coordination, strategy development, planning, administration, and monitoring of consistent readiness of all quality management, regulatory requirements, compliance and quality-improvement processes together with the team.

In the role as CQRO you are a member of the management team in Nacka Strand. You will lead, manage and develop the department with approximately 20 employees, the majority located at the SHL Healthcare manufacturing site in China. The CQRO position has currently two direct reports, one QA/QC manager (Team leader) at the manufacturing site in China and a Customer QARA Engineer in Nacka strand (position currently open). The CQRA work in close collaboration with the management team and colleagues within product development, project management, sales and finance. The role also includes authority contacts, customer contacts, customer interactions and customer communication in different stages of a project.

The role will require some travelling to the manufacturing site in China.

Role opportunitites

• As CQRO you become a key leader and management team member at SHL Healthcare, a fast-growing global company with high quality innovative products and long-term customer relations
• As CQRO you will have the opportunity to lead, develop and influence the future of the QA & RA strategy, department and personnel in a multi culture environment
• As CQRO you will be part of SHL Healthcare’s future efforts, developing new innovative products and solutions, adding value for customers, healthcare and patients
• As CQRO you will be part of an exciting journey together with a team of professional and skilled co-workers, colleagues and customers from different parts of the world
• SHL Healthcare is an attractive employer with a focus on well-being, codetermination, collaboration, kinship and personal development. The company offers solid terms and conditions for the employment.

Profile

Qualifications
• Master of Science or related education, alternatively relevant job experience
• Solid experience from leading Quality Assurance and Regulatory Affairs teams, within the medical devices industry
• In-depth knowledge of the trends within the quality/regulatory and performance improvement space ISO 13485, FDA, MMD
• Experience working with Quality Management Systems and processes within the Life science/MedTech industry
• Experience of working in a Global organization with international relations, especially with China is an advantage
• Experience from manufacturing is an advantage
• Experience as a leader for performance excellence and applied knowledge of a performance improvement methodology, such as Lean or Six Sigma is an advantage
• Experience from working in Project teams is an advantage.

Other
• Fluent in written and spoken Swedish and English
• High standard user of MS office. Experience from working in an ERP system and the ability to embed quality into the systems
• Able to travel regularly to the China factory and global customers

Key competencies and personality
• Excellent interpersonal- and communication skills
• Strong general management and demonstrated leadership skills
• Excellent problem - solver to maintain/increase compliance to meet all requirements.
• Ability to develop, formulate strategy and exercise good judgment
• Ability to work under pressure and meet deadlines
• Ability to inspire and build strong trust bounds at all levels

Contact

For more information, inquiries, interest and application regarding the Chief of Quality and Regulatory Officer at SHL Healthcare please contact Magnus Klingberg or Jenny Ringh, Senior Recruitment Consultants at PeakSearch.

Contact information:
Magnus Klingberg: magnus.klingberg@peaksearch.se , 070 678 09 92, 08 545 00 100.
Jenny Ringh: jenny@peaksearch.se , 070-235 81 99, 08-545 00 100

Apply for the position at http://www.peaksearch.se