Stockholm: Quality & Environmental Manager

We are recruiting a Quality & Environmental Manager

Human Care provides mobility solutions for people. Our products strive to serve as a natural part of life for all users. Our main product areas are: Mobility Aids, Lifting Solutions, Healthcare Beds, Convertible Chairs, and Bathroom Safety Products for people with reduced mobility. Human Care was founded in 1993 and has since created a proud history within patient care. With over 25 years of experience is reflected in a broad selection of premium products offering high customer value and satisfying every customer need. Human Care values diversity and welcomes employees with different experiences and backgrounds.

Our headquarter is by Liljeholmskajen in Stockholm, Sweden, with subsidiaries in Netherlands, Germany, the USA, Canada and Turkey.

About the job

As Quality & Environmental Manager you will support Human Care Group to meet company´s global quality management system (QMS) and environmental management system (EMS) requirements. You will be responsible for the company's compliance with relevant rules, directives and standards. You will work cross functionally in Human Care Group and together with colleagues responsible for quality and/or environmental work in each Human Care subsidiary, you will drive continuous improvement initiatives in the quality and environmental areas. You will support the Human Care Group's headquarters in regulatory matters and carry out reporting to and communication with the Swedish medicinal agency.

 

Main responsibilities

Quality Management System (QMS)

-         Support to maintain and improve the QMS and its compliance with relevant legislations and standards.

-         Support supplier selection and assessment.

-         Support production unites to keep quality control release documents up to date.

-         Perform investigation and root cause analysis when claim, non-conformity or incident report is registered at Human Care.

-         Perform supplier and internal audits (includes both QMS and EMS).

-         Responsible for quality assurance in product development projects.

-         Responsible for quality assurance in quality records and quality agreements. 

-         Responsible to manage regulatory reportable incidents to medical agencies (mainly Lakemedelsverket - the Swedish MPA)

 

Environmental Management System (EMS)

-         Report on the performance and effectiveness of the EMS.

-         Submit any needs for improvement of EMS to Top Management for review and action.

-         Establish and follow up on environmental objectives.

-         Ensure promotion and awareness of EMS requirements throughout the organization.

-         Arrange internal training in the EMS.

-         Responsible to manage reportable incidents to relevant European authorities (mainly in Sweden).

Qualifications

Required

BSc in Engineering, quality Management or at least 3 years of proven experience from quality work
Quality management system knowhow – ISO13485 or ISO9001
Environmental management system knowhow - ISO14001
Experience from product producing companies
Speaks and writes English fluently
Speaks and writes Swedish well
 

Desirable skills

Experience in medical device industry
Experience in product development
Experience in Medical Device legislations; MDD/MDR, US QSR
CE marking process knowhow – establishing technical file/DHF
Experience in medical device registration (uppermost the Swedish agency and US FDA)
Regulatory reportable incident management knowhow
Speaks fairly in Turkish
 

For more information, please contact Andreas Jansson (Recruitmore) andreas@recruitmore.se