Boston Scientific Principal Quality Engineer 

Netherlands, Limburg 

519032069

About the Role

The Principal Quality Engineer will ensure FDA and warehouse audit readiness. This position will be either hybrid or onsite located at the Kerkrade, NL site. The Quality team is responsible for quality and operational oversight to ensure processes are in compliance with Boston Scientific requirements, ISO 13485, EU MDR 2017/745, and 21 CFR 800 standards and regulations, as applicable to the warehouse and distribution center.

Your responsibilities include:

• Implement, maintain, and improve the Kerkrade Quality Management System.
• Responsible for working with Quality management, department personnel and other areas on process reviews and implementation of requirements to ensure site audit readiness
• Ensures Annual Global Quality Systems Objectives and Metrics are understood and achieved in line with BSC BestQuality Strategy.
• Plan and conduct scheduled internal audits to assess compliance with FDA, ISO, EU MDR, and internal requirements. To include audit scheduling, investigation, and evaluation of audit observation and findings, reporting, follow-up, and confirmation of follow-up actions.
• Drive continuous improvements in the distribution center
• Act as a coach/ mentor to aid development of junior staff members
• Pro-actively investigate, identify, and implement best in class Quality Systems practices and implement/manage improvement projects within the organization; (CAPA, VIP, QMP, StAR, Lean, 5S).
• Act as team/cross-functional team member/lead in supporting quality disciplines, decisions, and practices both internally & externally.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Collaborate with cross-functional colleagues regarding the impacts of enhancements and process changes.
• Drive awareness and compliance with applicable standard operating procedures/ work instructions / standards and regulations to meet, comply and champion all quality and regulatory commitments of Boston Scientific
• Is viewed as a leader in the areas of QSR and ISO/MDR standards within one’s own group, constantly promoting awareness of best industry practices making appropriate decisions using the Site QA Associate Director and Quality Systems Manager as the final arbitrator on critical quality decisions.

What we are looking for:

• 5+ Years lead auditor experience
• 5+ Years relevant experience in a GMP Medical Device Manufacturing environment
• Experience in a Distribution center is a plus.
• Green Belt certified (is a plus) with process management experience
• Familiar with quality tools and problem-solving techniques
• Team player with strong work ethic and positive mentality
• Computer literate
• Good social and communication skills
• Strong analytical skills, "self-starter" and eager to improve
• English language proficiency

What we offer you:

• Attractive benefits package - very competitive salary (including 8% holiday pay, 13th month and yearly bonus)
• 30 days of annual leave
• A very good pension scheme
• A stock purchase program
• Excellent training/development programmes to influence your career
• Inhouse gym facility (free of charge)
• Option to lease a (electric) bicycle
• Inspirational colleagues & culture
• Fast Growing and innovative environment
• A team-oriented company culture
• International opportunities