Post Market Quality Analyst 2 CR
hace 4 semanas
We are seeking a highly skilled Post Market Quality Analyst 2 CR to join our team at Hologic, Inc. This role will be responsible for supporting the Operational Excellence program and initiatives, as well as local and extended CSPOs, VIP projects, improvement initiatives, NPIs, product transfers, and implementation of new technologies.
Key Responsibilities- Support the development and implementation of quality metrics and reports related to the Post Market Surveillance Laboratory.
- Innovate processes to improve efficiency and ensure compliance with Post Market Surveillance requirements.
- Maintain, improve, and simplify procedures, processes, and methods.
- Support and promote the implementation of EHS programs to ensure people safety and environment health.
- Coordinate services with suppliers and availability of required supplies in house.
- Ensure testing, investigations are performed in accordance with procedures and on a timely manner.
- Support track and trending of complaints.
- Create and execute new procedures, new testing methods, validations, and any other compliance requirements.
- Make decisions based on risk thinking and implement tools such as PFMEA, Fault Tree Analysis (FTA), and risk evaluation.
- Review and approve complaints investigations in the QMS, as required.
- Ensure equipment is properly calibrated and controlled with the QMS.
- Ensure Preventive Maintenance program is implemented as required.
- Provide guidance to CSPOs, inspectors, technicians, supervisors, and engineers in technical matters related to Post Market Surveillance.
- Execute investigations such as OOTs, NCEs, CAPAs, IACAs, and/or similar.
- Drive for Results
- Planning
- Organizational Agility
- Listening
- Decision making
- Problem Solving
- Communication
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