Senior Quality Engineer

Additional Locations:  N/A

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

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.

Location: Onsite Kerkrade

Responsibilities 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
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating and resolving quality issues.
• 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).
• Actively participates in Strategic and site projects.
• Acts as the Quality Core Team member is a dedicated area or project.
• Coaches more junior team members in specific Quality systems and processes.
• 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.
• The Sr Quality Engineer may be required to support BSC activities & processes at our 3PL when required.

What are we looking for:

• 5+ years’ experience with bachelor’s degree or equivalent in a manufacturing environment
• Comprehensive understanding of the MDD/EU MDR, ISO standards and cGMP
• Demonstrates knowledge in teamwork, SAP, 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)

Preferred Qualifications:

• Experience with supply chain distribution and packaging
• Medical device industry experience

Requisition ID: 597187

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. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!