Director Quality Assurance Emea
vor 6 Monaten
Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.
In Germany, Abbott has more than 4,000 employees working in manufacturing, research and development, logistics, manufacturing, 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.
**W**orking at Abbott**
At Abbott, you can do work that matters and help people to live a healthier and full life, grow your career, and learn, be your true self. You will have access to:
- Career development with an international company where you can grow the career you dream of
- An attractive benefits package (e.g. attractive Abbott Pension Plan ,a company bike, employee stock purchase program)
- A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
- A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
- A challenging position in a fast-growing crisis independent industry
- To become part of a dynamic, highly educated, highly skilled, and motivated team
- Flat hierarchies, open appreciative mentality, and efficient, constructive lines of communication
- Multi-national environment, where we foster the development of our talents within the enterprise
Abbott Diabetes Care (ADC), Abbott GmbH is looking for Director Quality Assurance EMEA (M/F/d) based in Wiesbaden.
**Primary Objective of Position**
- Manage the EMEAP Regional QA and Affiliate QA teams
- Ensure EMEAP Regional (Commercial) QS compliance and respective processes across Commercial Affiliates for ADC in conjunction with the shared MIMS QS
**Major Accountabilities**
- Oversee and / or support internal ADC Affiliate audits including preparation of Corporate / Divisional Audits at Affiliates
- Ensure Quality System awareness and compliance in EMEAP:
- Utilize audit input for the Implementation of CAPAs and improvements
- Promote and support trainings / QS facilitation to the ADC organization on Quality System requirements.
- Maintain and/or develop QS compliance and effectiveness at Commercial Affiliates in collaboration with Subject Matter Experts (SME) and identify potential QS improvements for relevant QS elements or processes
- Support EMEAP and global Improvement Programs of ADC and OneAbbott.
- Sustain a professional cooperation with other Abbott Divisions in respect to maintaining and/ or developing a shared QS (e.g. “Multisite Integrated Mgmt. System MIMS”, OneAbbott)
- Partner with the Commercial Management at EMEAP HQ & Regions to support effective business operations and programs while maintaining compliance with policies, procedures and legal and regulatory requirements
- Maintain cross departmental relationships with the ADC Quality Organization (e.g. CQA / PQA / SQA etc..) as well as other Operations Functional Units of relevance (like Logistics etc.) in order to support those processes / interfaces
- Hire team staff as necessary, conduct annual performance reviews and set objectives in line with ADC Goals
- Build a team with high expertise to support the EMEAP area and ensure talent development within the team in their positions or for future responsibilities
- Establish a culture of teamwork, innovation and continuous improvement and high collaboration across the QA organization and with the commercial business operations in EMEAP
- Develop EMEAP experts to support the QS and EMEAP or global Improvement Programs
- Ensure that knowledge and experience acquired during professional life is transferred to other team members.
**Education**
- University / College Degree in Natural/Life Sciences, Technical Engineering, Medical or Quality Management (i.e. Bachelor/ Master Degree/ PhD, or equivalent)
- Other education may be acceptable in case of a relevant combination of education and experience, e.g. for Process
- or Quality-Management or closely related discipline (e.g. Medical Devices, Diagnostic or Pharmaceutical Industry) for five or more years in a comparable position
**Background**
- At least 5 years of experience in the Medical Devices, Diagnostic or Pharmaceutical Industry, Competent Authority, related Industry Association or equivalent
- Proven strong knowledge of medical device standards, such as ISO 13485, ISO 9001, MDR / IVDR or Pharmaceutical Regulations, etc. and a high degree of responsibility and ownership for ensuring the highest level for QA
- Influencing Management and strong Leadership Competencies together with a long experience related to working in an international environment / cross-functional team and/or executing respective programs / projects
- Lead Auditor (e.g. ISO 13485) training / c
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