Quality Specialist Capa and Risk Management
Vor 2 Tagen
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.
In Germany, Abbott has more than 3,000 employees working in manufacturing, research and development, logistics, sales and marketing. They are located at Abbott's German headquarters in Wiesbaden and its sites in Hanover, Neustadt am Rübenberge, Wetzlar, Eschborn, Cologne, Jena and Hamburg. Abbott Automation Solutions in Hamburg (formerly GLP Systems) is now Abbott.
Abbott Automation Solutions (AAS) in Hamburg is looking for a
Specialist Quality Systems & Compliance (M/F/d)
based in Hamburg, Germany reporting to the Director Instrument Quality in Texas, USA. The Manager Quality Systems & Compliance will be leading site Inspection/audit readiness including upcoming inspection preparation, manages Legal Manufacturer responsibilities, acts as Quality Representative for the Business Unit AAS during implementation of new IVDR (in vitro diagnostics regulations) standards and manages the Quality Systems team on site.
Major Responsibilities:
- Prepare the AAS Quality organization for upcoming inspections/audits including inspection logistics. Representative for internal and external audits
- Maintain measurable compliance standards throughout the Quality organization and partner with Divisional Regulatory Compliance group
- Manage all activities related to Legal Manufacturing activities (oversight)
- Act as Quality representative for BU AAS during IVDR implementation project
- Acts as Person Responsible for Regulatory Compliance (PRRC) under the In Vitro Diagnostic Device Regulation 2017/746 (IVDR)
- Work closely together with other Abbott Quality organizations to establish regular knowledge and experience sharing
- Provides Quality System consulting expertise to areas
- Continuous consideration of process improvements and implementation
- Ensures training and development for functional area is provided and documented
- Implementation and maintenance of operating procedures relevant to the area
- Ensures process ownership for relevant processes within Quality Systems department
- Priority and Resource Management, Plan and manage budgets for functional area
- Identifies potential quality issues
- _ B_eyond the general legal obligation to prevent accidents, Manager Quality Systems & Compliance is assigned certain duties in respect to environmental protection and work safety which tie in directly with his/her position within the company. It is his/her task to support actively Abbott’s environmental goals, to keep the sequence of operations free of risks, and to ensure employees under his/her supervision follow the rules for safe behavior at work
Your Profile:
- Degree in science, technical or engineering related discipline
- Preferably third-party qualification in Quality Management
- 5 years experience in regulated industry, at least one year in IVD or Medical Device industry in Quality or Regulatory Affairs role
- 5 years of experience in people management
- Familiarity with regulatory requirements like ISO13485, 21CFR820, IVDR, cGMP
- Excellent English and **German** communication skills
Abbott Germany has a range and variety of jobs on offer in a positive and dynamic environment that allows you to maintain a healthy work-life balance. We provide development opportunities as part of our comprehensive Talent Management Program. Your contribution to the company’s success will be rewarded with a competitive salary package. We offer comprehensive benefits to suit the lifestyles of all our employees, from a retirement plan that is far above market average, a save-as-you-earn program, to educational scholarships for children, and health management initiatives for staff and their dependents.
AN EQUAL OPPORTUNITY EMPLOYER - Abbott welcomes and encourages diversity in our workforce.
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