Quality Assurance Manager

What are you going to do?

You will be responsible for maintaining the QMS and SOPs supporting Medeco B.V. and Mediq Own Brands (MOB). The new Quality Assurance Manager will act as a lead during audits from the Notified Body and during inspections from the Competent Authorities if applicable. He or she will perform audits and ensure a quality system required by ISO 13485/ISO9001 is managed and implemented. On a daily basis you will ensure quality operations and compliance and support the Product Management team with requested product related quality documentation. 

Further responsilibities are:

• Implementing CAPAs and ensuring non conformities and complaints are investigated
• Implement quality management processes
• Conduct supplier evaluation and audits
• Prepare reports, procedures and statistical information for management review
• Work on ISO compliance, maintaining and implementing new relevant standards
• Act as the primary point of contact for stakeholders with Mediq business units regarding Quality Assurance and Quality regulations.
• Perform root cause analysis, offer quality related training and possess quality qualifications
• Collaborate with a diverse team of individuals
• Support the business in maintaining all relevant regulations as well as internal standards
• Undertake project work ensure  continuous improvement for projects and processes?
• Lead the further implementation of Eudamed

What is your background?

• Minimum Batchelors level degree in law, medicine, pharmacy, engineering or another relevant scientific discipline
• At least 4 years of professional experience in quality management systems in the medical device or in vitro diagnostic device fields.
• Proven track record of auditing knowledge and skills
• Will have experience in working in a managerial/team leader position
• Experience with internal ,external audits and supplier audits and management reporting
• Must be self-motivated and a highly organised individual with robust problem solving techniques
• Regulatory Affairs knowledge is nice to have
• Good written and verbal command of English
• Experience of working within a healthcare environment is preferred.