Boston Scientific Quality Engineer 

Netherlands, Limburg 

797640319

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 Quality Engineer II 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. The Quality Engineer may be required to support BSC activities & processes at our 3PL when required.

Your responsibilities include:

• Pro-actively implements Quality standards and procedures in the operational processes, to ensure that processes are executed per Corporate and Regulatory requirements.
• Understands and applies 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 (e.g. SAP improvements, implementation and training).
• Act as a team member in continuous improvement activities, NCEPs, CAPA and lean initiatives from a quality perspective, for both internal and external customers.
• 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).
• Understands and utilizes problem solving methodologies; (CAPA, Is/Is not diagram/Fishbone diagram, Pareto, FMEA).
• Support incoming inspection process of materials (risk-based approach).
• Acts as the Quality Core Team member is a dedicated area.
• Flexibility to perform general QA related activities.
• Drives 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 Subject Matter Expert (SME) in audits.
• Collaborates with cross-functional colleagues regarding the impacts of enhancements and process changes.

What are we looking for:

• 3+ years’ experience with 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 & 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)