OBS! Ansökningsperioden för denna annonsen har
passerat.
Arbetsbeskrivning
Are you passionate about making life better for patients worldwide?
If the answer is yes, you think just like us. We are a world-leading medical solutions company, designing and supplying medical solutions to enhance performance in healthcare – from the hospital to the home. We’re looking for a Global Quality System Manager to help improve outcomes for healthcare professionals and their patients.
The role:
We have an opportunity for a Global Quality System Manager, based with our Gothenburg HQ, to drive the awareness, ownership and overall usability of our quality system framework. You will act as a key resource for implementing best practice across the organisation whilst mentoring and leading a team of Quality System Engineers. You will become an ambassador for our quality system function throughout the business and develop continuous improvements which meet our ready changing environment.
Key Accountabilities:
Improve and refine the Global Quality Systems with focus on simplicity, usability and consistency.
Support the organization by providing guidance in quality systems requirements and its implementation.
Monitor and report Quality System issues to management and executives.
Act as a change agent whilst driving improvements globally.
Oversee quality activities including document control, CAPA, non-conformities etc.
Support and host external regulatory audits.
Ensure quality system policies, procedures and work instructions are updated and compliant.
Act as part of the Quality System leadership team.
Lead and coach the Quality System Engineers team in order to secure continous development of adequate competence, efficient working methods, optimal resource planning and a stimulating environment.
Qualifications & Experience
Demonstrable experience in a similar global Quality System Manager role.
Direct experience supporting and/or leading third party audits (ISO registrars, FDA or other regulatory authorities)
Prior working experience within a regulated environment: MDD, MDR, QSR, ISO 13485, ISO 9001, MDSAP preferred.
Proven stakeholder management across complex business matrix
Similar exposure to a culturally diverse global organisation
Proven ability to mentor and professionally develop a team
Lead auditor certification would be beneficial
Fluent written and spoken English