Quality Assurance Manager
9 hours ago
We are seeking a highly skilled Quality Assurance Manager to join our team at Abbott Laboratories. As a key member of our quality team, you will be responsible for initiating and executing Field Action related activities, serving as a key contact for internal and external customers, and implementing and executing the Field Action process through completion.
Key Responsibilities- Prepare all Field Action documentation and issuance of Field Action packages.
- Develop strategies and project manage Field Action activities by working cross-functionally, then gaining approval from Senior Leadership.
- Independently complete Field Action documentation in a timely manner and in accordance with business standards.
- Work with the appropriate business functions to assess Field Action communication effectiveness as needed.
- Responsible for managing and tracking Field Action responses and updates to regulatory agencies, ensuring timely submission to the appropriate regulatory authorities.
- Responsible for compiling the Field Action documentation package and ensuring all documentation is complete and accurate.
- Acts as the Field Action subject matter expert for business audits.
- Responsible for managing and tracking responses to regulatory agencies.
- Project manages quality escalations and works cross-functionally with appropriate SMEs.
- Minimum of 7 years in Quality function.
- Experience with presenting to Executive Management.
- Ability to project manage cross-functionally.
- Highly organized during fast-paced environment.
- Sound decision-making skills contributing to high levels of competence, confidence, and credibility.
- Previous experience in completing Field Action packages or understanding of Field Action processes.
- Familiarity with standards and regulations such as ISO 9001/13485, MDSAP, MDR/IVDR.
- Strong and well-developed interpersonal communication skills.
- Continuous improvement methods and application, e.g., Lean, Six Sigma.
- Experience dealing with international locations and businesses.
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 114,000 colleagues serve people in more than 160 countries.
We offer a comprehensive benefits package, including career development opportunities, free medical coverage for employees, an excellent retirement savings plan, tuition reimbursement, and a company recognized as a great place to work in dozens of countries around the world.
Join us at Abbott Laboratories and be part of a team that makes a difference in people's lives.
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