Boston Scientific Senior Quality Engineer-S/4Hana Deployment 

Netherlands, Limburg 

188340500

About the role:

Collaborates with Quality management to recommend, design and implement functional process improvements. Develops, establishes and maintains quality methodologies, systems and practices which meet BSC, customer and regulatory requirements. The Senior Quality Engineer serves as a Quality representative in the Core Team to improve awareness, visibility and communication on quality initiatives to support assigned departmental, functional, site, divisional and corporate quality goals and priorities. In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

Your responsibilities will include:

• Pro-actively demonstrate leadership and seniority in the implementation of all Quality standards and procedures in the operational processes, to ensure that processes are executed per Corporate and Regulatory requirements.
• Pro-actively implements Quality standards and procedures in the operational processes, to ensure that processes are executed per Corporate and Regulatory requirements.
• Represent the business user by working closely with Stakeholders to translate User Requirements into Business User Stories and the ‘Who, What, Why’ Acceptance Criteria.
• Analyze and translate User Requirements distinctly and assess options before arriving at the aspired solution to improving current systems to increase productivity.
• Coordinating the User Requirements, aligning to Testing Scenarios, creation of test cases, and execution of test cases 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 each of the key Applications to enhance the knowledge base across quality and D&L workstream.
• Proactively influencing functionally, regionally, in areas of new concepts, adoption of Best
• Coordinating and liaison with the other Magellan Workstreams, Business Process Leads, SME’s, Communities of Practice’s, IT Solution Architects/COE and Stakeholders across the network to develop a strong and deep pool of expertise across Service to Cash.
• Collaborate with the broader Magellan Workstreams, IT Solution Architects/ COE and the other Magellan Workstreams in a Scalable Agile Framework/DevOps methodology, to enable rapid deployment.
• Work with the team members and other stakeholders on analyzing the impact of the system change and proper remediation plan for any risks raised.
• Support with preparing/gathering the documentation and testing of the new system functionalities.
• Pro-actively investigates, identifies and implements best in class Quality Engineering practices and implements/manages improvement projects within the organization (VIP, QMP, Star, Lean, 5S).
• Flexibility to perform general QA related activities.
• Support and prepare for site level internal and external audits and act as Subject Matter Expert (SME) in audits.

Who are we looking for:

• 5+ years’ experience with Bachelor’s Degree or equivalent in a manufacturing environment
• 2+ years of Systems/Applications 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, fully motivated to achieve and demonstrate best practices in line with the department & 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)

Preferred Qualifications:

• Medical device industry experience
• Working knowledge of SAP S4Hana service management and/or quality processes which covers data management
• Gathering, analyzing, and interpreting data to understand gaps and risk assessment
• Previous experience of a major program introduction/upgrade, ideally within an IT/Systems or Business representative role is preferable.
• Sense of urgency and commitment to execution