Principal Quality Engineer

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.

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.

Understands, interprets, and applies quality principles and processes to ensure compliance with Corporate, FDA, EU MDR, and ISO regulations and standards with unyielding integrity. Demonstrates the appropriate expertise to assess complex overall Quality Assurance elements and activities in accordance with regulations, standards, and business strategies. Independently processes and supports the awareness and ability to apply the correct principles, ethics, guidelines, and procedures to assess compliance.

Ability to clearly communicate technical and compliance related information verbally and in writing to ensure the intended audience understands the potential impact of the information.

• 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.

• 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
• Good social and communication skills
• Strong analytical skills, "self‑starter"and eager to improve

• 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 &…