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Senior Quality Engineer

2 maanden geleden


Kerkrade, Limburg, Nederland Boston Scientific Voltijd
About the Role

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.
Requirements
  • 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).
Preferred Qualifications
  • 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.