Senior Quality Assurance Specialist
3 weken geleden
We are seeking a highly skilled Senior Quality Engineer to join our team at Boston Scientific. As a Senior Quality Engineer, you will play a critical role in ensuring the quality and compliance of our medical devices.
Key Responsibilities- Collaborate with Quality management to recommend, design, and implement functional process improvements.
- Develop, establish, and maintain quality methodologies, systems, and practices that meet BSC, customer, and regulatory requirements.
- Serve as a Quality representative in the Core Team to improve awareness, visibility, and communication on quality initiatives.
- Proactively demonstrate leadership and seniority in the implementation of all Quality standards and procedures in operational processes.
- Apply sound, systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues.
- Partner with the Global Systems Project Team to support Quality Systems information needs for surveillance of product performance.
- Act as a team member in continuous improvement activities, NCEPs, CAPA, and lean initiatives from a quality perspective.
- Investigate, identify, and implement best-in-class Quality Engineering practices and manage improvement projects within the organization.
- Utilize problem-solving methodologies, including CAPA, Is/Is not diagram, Fishbone diagram, Pareto, and FMEA.
- Participate in Strategic and site projects and act as a Quality Core Team member in dedicated areas or projects.
- Coach more junior team members in specific Quality systems and processes.
- Drive awareness and compliance with applicable standard operating procedures to meet, comply, and champion all quality and regulatory commitments of Boston Scientific.
- Support and prepare for site-level internal and external audits and act as a Subject Matter Expert (SME) in audits.
- 5+ years' experience with a Bachelor's Degree or equivalent in a manufacturing environment.
- Comprehensive understanding of the MDD/EU MDR, ISO standards, and cGMP.
- Demonstrates knowledge in teamwork, SAP, project management, problem-solving, and risk management techniques.
- Effective team member, 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.
- Good knowledge of the English language (verbal and written).
- Experience with supply chain distribution and packaging.
- Medical device industry experience.
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