Quality Systems & Compliance Specialist

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.

At Boston Scientific, we’ll give you the opportunity to utilize and develop your skills and competencies by working in a team of diverse and high-performing employees, tackling some of the most important health industry challenges. 

Remote Eligible: Hybrid 

Onsite Location(s): Kerkrade

About the Role:

The Quality Systems & Compliance Specialist (P3) will ensure audit readiness in the Kerkrade distribution center and in the EMEA affiliates. This position will be hybrid or onsite and located at the Kerkrade, NL site.  The Quality Systems team is responsible for full quality system oversight to ensure processes are in compliance with Boston Scientific requirements, ISO 13485, EU MDR 2017/745, 21 CFR Part 820, and local standards and regulations, as applicable to the distribution centers and country affiliates.

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.

Your responsibilities include:

• Implement, maintain, and improve the Kerkrade and EMEA Quality Management System.
• Responsible for working with Quality management, department personnel and other areas on process reviews and implementation of requirements in compliance programs.
• Ensures Annual Global Quality Systems Objectives and Metrics are understood and achieved in line with BSC Best Quality Strategy.
• Plan and conduct supplier and 3PL assessments throughout the EMEA region.
• Support Supplier Quality responsibilities at Kerkrade.
• Perform internal audits at Kerkrade and affiliate sites within EMEA region.
• Support and prepare for site level internal and external audits.
• Drive continuous improvements within Kerkrade and EMEA region.
• 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

What we are looking for:

• 5+ Years relevant experience in the Medical Device, Pharma or Food environment.
• Green Belt certified (is a plus) with process management experience
• Preferably has Auditing (Lead Auditor), Supplier Assessment, and Quality Systems 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
   

Are you ready to take on this challenge?
Does this position sound like the next step in your career? We look forward to receiving your application! Join a team that works together to find solutions that make a difference!

Requisition ID: 619650

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!