Quality Systems, Sr Manager
hace 2 semanas
At Boston Scientific, we are committed to advancing science for life. As a Quality Systems, Sr Manager, you will have the opportunity to lead a cross-functional team in developing procedures that will lead to a successful launch of a PMA product containing MOAO and prepare the manufacturing site to host successful inspections by FDA and external audits.
Key Responsibilities- Supervise and assure a flawless execution of the corrective and preventive action system (CAPA).
- Supervise the correct usage of investigation tools and techniques in order to obtain effective corrective and preventive actions over issues managed in different quality systems including eCAPA.
- Ensure follow-up of action items related to the quality system to facilitate closure of CAPAs and NCEPs as required.
- Drive a proactive quality culture based on substantial compliance by providing relevant training, coaching, driving actions, and disseminating critical information.
- Support QA Director during preparation, management, and hosting of external audits.
To be successful in this role, you will need:
- Strong project management skills.
- A bachelor's degree or above in a technical/science career (Industrial, Electronic, Biotechnology, Electromechanical Engineering, etc.).
- 10 years of medical experience.
- Experience hosting quality audits/FDA inspections.
- 90% English proficiency.
- Master's degree desirable.
- ASQ Certification.
- Knowledge of Six Sigma, Lean, APQP, or similar tools.
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Quality Assurance Systems Director
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