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Senior Quality Engineer
2 maanden geleden
We are seeking a highly skilled Senior Quality Engineer to join our team at Boston Scientific. As a key member of our Quality Assurance team, you will be responsible for collaborating with Quality Management to recommend, design, and implement functional process improvements.
Key Responsibilities- Develop and maintain quality methodologies, systems, and practices that meet BSC, customer, and regulatory requirements.
- Represent the business user in translating User Requirements into Business User Stories and Acceptance Criteria.
- Analyze and translate User Requirements to identify solutions that improve current systems and increase productivity.
- Coordinate User Requirements, Testing Scenarios, test case creation, and execution to support the Testing Phase and network-wide Deployment.
- Liaise with the Training team and Site Super Users/Business Process Leads/Subject Matter Experts to support training plans for key Applications.
- Proactively influence functionally and regionally in areas of new concepts, adoption of Best Practices, and process improvements.
- Collaborate with the broader Magellan Workstreams, IT Solution Architects/COE, and other Magellan Workstreams in a Scalable Agile Framework/DevOps methodology to enable rapid deployment.
- Support the team in analyzing the impact of system changes and developing remediation plans for identified risks.
- Investigate, identify, and implement best-in-class Quality Engineering practices and manage improvement projects within the organization.
- 5+ years' experience with a Bachelor's Degree or equivalent in a manufacturing environment.
- 2+ years of Systems/Applications experience in SAP; Business Process Leads/Subject Matter Experts.
- Working knowledge of ERP systems combined with knowledge of key business processes.
- Comprehensive understanding of the MDD/EU MDR, ISO standards, and cGMP.
- Effective team member with strong analytical skills, eager to improve and results-oriented.
- Good knowledge of the English language (verbal and written).
- Medical device industry experience.
- Working knowledge of SAP S4Hana service management and/or quality processes.
- Gathering, analyzing, and interpreting data to understand gaps and risk assessment.
- Previous experience in a major program introduction/upgrade, ideally within an IT/Systems or Business representative role.
This role starts with a fixed-term contract and requires working onsite in our European Distribution Center office located in Kerkrade, The Netherlands.