Quality Systems Manager - Nürnberg (m,f,d)

Who are Advanced Medical Solutions? When we say we're a world leading independent developer and manufacturer of innovative and technologically advanced products for the global advanced wound care, wound closure and surgical markets, we're not joking. But we're much more than that... With over 700 employees across the globe, we pride ourselves on being able to create an engaging and challenging place of work, developing individuals to the best of their abilities, and providing the correct environment to foster innovation, growth and meaningful work. We're highly dependent on the creativity of our employees for our future growth and success. Our motto 'Care, Fair, Dare' summarises our culture, and defines the principles of how we operate as one team to achieve success.AMS provides equal employment opportunities for all applicants. We highly value and encourage diversity across our workforce meaning that no one will be discriminated against because of their gender, race, age, nationality, disability, or any other protected characteristic as prohibited by law. Job PurposeQuality Management System is compliant with local, national and international legal requirements (ISA 13485:2016, MDD, MDR, cGMP-USA) and fit for purpose, adequate and effective Required degree in engineering, microbiology, chemistry or associated fields or equivalentKey Responsibilities / Main DutiesManage and provide leadership to the Quality Systems teamAct as site Management representativeResponsible for managing the QM System including the implementation of the upcoming new European Medical Device Regulation Define, implement and report on key performance indicators Support key project teams (QM Reviews, Material Review boards, etc.)Support the quality deliverables of New Product Development that they are designed and developed in compliance with design control and validation requirementsPerform and support internal, corporate and external audits and inspections, ensure timely and adequate responsesInterface with relevant stakeholders in relation to compliance issues this includes implementation of GxP in compliance with regulatory requirements and continuous improvementDevelop effective data collection and reporting systems to meet regulatory requirements and management information needsDevelop specific measurable Quality goals and objectives; and the plans to accomplish those goalsDevelop the staff skills, abilities, and experiences for succession planning Perform other related duties as assigned Person SpecificationRequired degree in engineering, microbiology, chemistry or associated fields or equivalent.The role is based in Nürnberg.The role involves regular trips to Neustadt and Domazlice.Candidate must be fluent in German and good in English.Skills/KnowledgeRelevant experience of working in the medical device area, preferably in a QA role, alternatively in a regulatory roleMinimum 2 years’ experience in a wide breadth of OA or Regulatory roles At least 2 years of Medical device industry experience preferredMust have strong understanding of applicable Quality System Regulations and ISO quality requirements.Ability to plan and/or oversee quality system/processes, documents, and vendor audits/assessmentsExcellent German and English language skills (written and verbal)Ability to work independently on own initiative with minimal supervisionAble to deliver to critical deadlines – excellent organisational and time management skillsTeam PlayerExcellent negotiation and influencing skillsSolid oral and written communication skills (medical personnel)Ability to manage multiple projects