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Quality Assurance Manager
2 maanden geleden
We are seeking a highly skilled Quality Manager to join our team at Boston Scientific. As a leader in medical science for over 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life.
Key Responsibilities- Proactively demonstrate leadership in the implementation of all Quality standards and procedures in operational processes, ensuring compliance with Corporate and Regulatory requirements.
- Foster a diverse workplace that enables all participants to contribute and develop to their full potential in pursuit of organizational objectives.
- Exercise technical autonomy through developing and managing an efficient and effective Quality Management System, complying with current medical devices standards and regulations.
- Participate in the local business management team to solicit input and consensus support for quality decisions, compliance with procedures and standards, and implementing continuous improvements initiatives and compliance programs.
- Provide vision and leadership for strategic projects with significant impact within the site, region, or globally.
- Collaborate with cross-functional colleagues regarding the impacts of enhancements and process changes.
- Participate in the internal audit program and lead the preparation and execution of audits by external parties.
- Responsible for NCEP & CAPA management and Supplier Management activities.
- Responsible for sustaining Third Party Logistics (3PL) activities from a Quality perspective and work on process improvements in collaboration with 3PL stakeholders.
- Collaborate and liaise with Global Quality Systems Stewards and relevant working groups to drive continuous improvement.
- May direct and control the activities of the Quality budget as it applies to their site/region.
- 7+ years' MedTech experience with a Bachelor's Degree or equivalent and 3-5 years of supervisory experience.
- Comprehensive understanding of the EU MDR, ISO standards, and cGMP.
- Demonstrated experience in team management and development.
- Experience in SAP ECC/S4 HANA, project management, problem-solving, and risk management techniques.
- Effective leader, fully motivated to achieve and demonstrate best practices in line with the department and global objectives.
- Good social and communication skills.
- Strong analytical skills, eager to improve and results-oriented.
- Advanced knowledge of the English language (verbal and written).
- Experience with supply chain distribution and packaging.
- Experience with 3rd Party logistics.
- Medical device industry experience.
