QA Manager - Manufacturing - Frankfurt Main - (m,f,d)

The QA Manager Manufacturing is responsible for all Quality related activities, compliance to Sirtex QMS and applicable global regulations, and Quality team members located at the manufacturing facility in Frankfurt.Manage, lead, and direct the efforts of the Frankfurt site Quality team members to ensure that manufacturing related processes and activities comply with the applicable global medical device regulations (e.g., FDA, EU, etc) and Sirtex Quality Management System requirements.Host and lead internal and external audits of the manufacturing facility and manages follow-up actions as required.Participate and deploy products or process changes at the manufacturing facility, ensuring compliance to global medical device regulations and Sirtex Quality Management System requirements.Collaborate with other functional teams to identify, investigate, and resolve product quality issues in a compliant and effective manner.Manage, select, train and develop staff as well as conduct performance reviews and performance management activities.Ensure compliant investigations are conducted in a timely manner and in accordance with medical device regulations and Sirtex Quality Management system.Participate in supplier qualification, audit, ongoing monitoring, and supplier improvement activities.Develop and deploy Quality System related processes, tools, training and metrics to enable Sirtex to meet business needs and comply with global medical device regulations.Lead CAPA, post market surveillance and other quality improvement efforts at the manufacturing site.Provide key quality trending information and data for use in periodic reviews.Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating and resolving quality issues.Use statistical tools to analyze data, make acceptance decisions, and improve process capability (Six Sigma, SPC, DOE).