Director Quality Assurance EMEA (m/f/d)
Location
Delkenheim, Wiesbaden | Germany
Job description
Director Quality Assurance EMEA (m/f/d) page is loaded
Director Quality Assurance EMEA (m/f/d)
Apply locations Germany - Wiesbaden-Delkenheim time type Full time posted on Posted 5 Days Ago job requisition id 31078752
JOB DESCRIPTION:
Abbott is a global health care 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 r ecognized 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
- Ensure QS compliance at the same level across EMEAP by applying Abbott / ADC Quality policies, programs and a consistent execution of respective processes and procedures
- 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
- Highly experienced with IVD, Medical Devices or Pharmaceutical Quality Systems and their effective application
- 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 / certificate is preferred.
- Great interest, sense and understanding of Commercial Business Operations and EMEAP Affiliate Cultural Diversity.
- Strong interpersonal, communication and negotiation skills.
- Fluent English language in spoken and written format. An additional language (spoken/written) is of advantage.
- Ability to travel up to about 25% of the time
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life . Abbott is an Equal Opportunity Employer, committed to employee diversity.
We ask for your understanding that we only consider online applications via our online application portal. Applications by email or post cannot be processed. Original documents will not be returned.
Connect with us at , on LinkedIn at , on Facebook at and on Twitter @AbbottNews and @AbbottGlobal.
The base pay for this position is
N/A
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:
Operations Quality
DIVISION:
ADC Diabetes Care
LOCATION:
Germany > Wiesbaden-Delkenheim : G01
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Yes, 25 % of the Time
MEDICAL SURVEILLANCE:
Not Applicable
SIGNIFICANT WORK ACTIVITIES:
Not Applicable
About Us
The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges.
We invite you to explore opportunities at Abbott , to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.
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