Quality Systems Specialist (m/f/d)

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.

• →Support and document KPIs related to the monthly Audit/change control/QMS objectives. Also, must provide mitigation, correction, and improvements plans in case of unaccomplished with the KPIs targets.
• →Work hand in hand and directly with the operating groups and the Enterprise team to provide guidance, knowledge, and monitoring of all activities within the Audit/QMS processes, analyze and working on the projects in conjunction with the stakeholders.
• →Coordinate cross-functional teams to ensure successful project execution.
• →Provide guidance and experience in interpreting policies, regulations and procedures to ensure compliance.
• →Support the process of self-inspections, internal and external audits, participate in the resolution of the findings to the applicable QMS.
• →Lead and participate in projects within the Audit/QMS processes and Automation
• →In case of acting as an owner for documents or processes must assure that all activities related are updated and aligned with QMS applicable requirements.

• Requires a bachelor’s degree in life science, engineering, or a related degree. (eg Pharmacy, Biomedical Engineering)
• Fluent in English
• Project management Skills.
• Lead or Internal Auditor certification in QMS. (eg ISO 13485 or GMP)
• 4+ years’ experience in a quality role in the health care industry with a high focus on ISO 13485 and/or GxP requirements. (eg Good Distribution Practice (GDP), Good Manufacturing Practices (GMP)).

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 

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