Senior Quality Systems Specialist

Additional Locations: Belgium-Diegem; Czech Republic-Prague; France-Voisins le Bretonneux; Germany-Düsseldorf; Italy-Milan; Netherlands-Kerkrade; Poland-Warsaw; Spain-Madrid

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

The Principal Quality Systems Specialist will provide Quality Systems support to the Europe, Middle East and Africa (EMEA) region. This position will be onsite (hybrid) and may be located at any EMEA BSC location.  The Quality Systems team is responsible for full quality system oversight and specific functional responsibilities (Management Controls, Training, Audits, Supplier, Document and Records Control, and NCEP/CAPA) for Boston Scientific. 

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

Your responsibilities include:

• Implement, maintain, and improve the 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 scheduled internal audits to assess compliance with FDA, ISO, 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.
• Assess potential new suppliers for technical, quality and manufacturing capabilities.
• Plan and conduct supplier and 3PL assessments.
• Support and prepare for site level internal audits and act as Subject Matter Expert (SME) in audits.
• Provide functional support as an SME as applicable to internal & external functions for internal audit and customer feedback processes.
• Drive continuous improvements in the internal audit and customer feedback processes within the EMEA region.
• 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.
• Execute the testing and training development for future rollouts of business applications.
• 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 Quality Systems Manager/ Site QA Director as the final arbitrator on critical quality decisions.

 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

Requisition ID: 591843

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!