Quality Assurance Specialist
18 uur geleden
We are seeking a highly skilled Quality Engineer II to join our team at Boston Scientific. As a Quality Engineer II, you will play a critical role in collaborating with Quality management to recommend, design, and implement functional process improvements. You will develop, establish, and maintain quality methodologies, systems, and practices that meet BSC, customer, and regulatory requirements.
Key Responsibilities- Proactively implement quality standards and procedures in operational processes to ensure compliance with corporate and regulatory requirements.
- Understand and apply quality principles to support an effective overall quality system.
- 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.
- Proactively investigate, identify, and implement best-in-class quality engineering practices and implement/manage improvement projects within the organization.
- Understand and utilize problem-solving methodologies, including CAPA, Is/Is not diagram/Fishbone diagram, Pareto, and FMEA.
- Support incoming inspection process of materials using a risk-based approach.
- Act as a Quality Core Team member in a dedicated area.
- 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.
- Collaborate with cross-functional colleagues regarding the impacts of enhancements and process changes.
- 3+ years' experience with a bachelor's degree or equivalent.
- Comprehensive understanding of the QSR, cGMP, and ISO/MDD/MDR standards.
- Demonstrates knowledge in teamwork, 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).
As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate.
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