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Senior Quality Systems Manager EMEA

Boston Scientific's hybrid workplace includes remote and onsite roles. By applying to this position, you will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.

Remote Eligible:  Hybrid
Onsite Location(s): 

Kerkrade, IE

Additional Locations: Netherlands-Kerkrade; Netherlands-Maastricht

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - Caring - 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:
Manages the Quality Systems organization across the EMEA region and European Centre of Operations (ECO), Kerkrade. Develops, establishes, and maintains the quality assurance programs, policies, processes, procedures, and controls ensuring that performance and quality of products conform to established standards and regulatory agency guidelines to ensure continued customer satisfaction. Responsible for implementing continuous improvements and providing vision and leadership for strategic projects, creating an entrepreneurial environment. Provides leadership that results in the implementation and achievement of the quality policy and functional objectives including initiatives in conjunction with the Director of Quality Assurance.  

 

Location: Kerkrade, The Netherlands.
Work Mode: Hybrid.
 
Your Responsibilities Include:

  • Day to day management of the Quality Systems function; Management, coordination and development of the following processes and groups working within the function - Management Review, CAPA, Internal Audit, Strategic Quality initiatives & objectives, CAPA Projects, Documentation Services and Supplier Quality Assurance. Maintenance of the ECO Site ISO 13485 accreditation status and support of EMEA Affiliate ISO:9001 and ISO: 13485 certification statuses. Compliance of site & regional Quality System activities to corporate requirements and FDA, MDR, TGA, PAL & CMDR regulations for Medical Devices; Support and facilitation of external audits. Drive strategic quality improvement projects to improve patient care and internal & external customer satisfaction. Develop and monitor department budgets and determine appropriate staff levels, schedules, and resources. Establish cross-functional team relationships & apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving technical & quality issues. Support the ECO Quality Operations Manager & Regional Quality Managers in all quality system aspects. Influence and define functional, departmental, global quality and divisional policies & procedures through involvement with cross-functional initiatives. Recruits, coaches, and develops organizational talent; Fosters a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives. Keeps the organization's vision, quality policy and values at the forefront of decision making and action. Demonstrates effective change leadership; Builds strategic partnerships to further departmental and organizational objectives. May serve as Regulatory Affairs PRRC (Person Responsible for Regulatory Compliance) Representative (Article 15 of the Medical Device Regulation 2017/745) ensuring that conformity of devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released.  

 

  • Quality Compliance: Ensures the Quality System is substantially compliant to GMP/QSR practices and standards as defined by the FDA, ISO and regulatory bodies in close coordination with the Quality Systems Manager. Works with Senior Management to identify areas of the quality system needing improvement. Takes a leadership role in developing and implementing new techniques and initiatives to enhance the quality management system on site; Maintains site compliance to external standards.

 

  • Quality Metrics & Communications: Develops and generates quality metrics reporting/tools as well as process improvements. Responsible for trending/analysis of any Quality data and develops/ maintains SOPs for recording, evaluation and reporting of Quality and reliability data. Shares periodic information across the Regional Quality Team on local issues, with the purpose of soliciting input on best practices and/or seeking consistent solutions to common problems; Provides the local management team with periodic reports on appropriate quality metrics; Establishes cross-functional team relationships; Where applicable, establishes and fosters relationships with local medical device industry groups to advance the interests of Boston Scientific in matters of quality and compliance.


Management Requirements:

  • May lead a group or team of employees in the achievement of organizational goals.  Guide, coach, direct, and develop direct reports, and if applicable, drive those practices throughout their organization.
  • Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
  • May direct and control the activities and budget of one or more functional areas, divisions, product groups, projects/programs and/or operations.
  • Monitor and ensure compliance with company policies and procedures (e.g. federal/country and regulatory requirements).

 
What we are looking for:

  • B.S. Degree with minimum of 5+ years’ experience in quality for medical devices, pharmaceuticals, food or other suitable discipline.
  • Demonstrated leadership & people management experience within a functional management role.
  • Comprehensive understanding of the QSR, cGMP and ISO/MDD standards.
  • Excellent communication skills with the ability to influence others.
  • High level of initiative & autonomy through continuous questioning of current practices.
  • Fluent in English.
  • Effective team member, motivated to achieve and demonstrate best practices in line with the department & global objectives.
     

 

Requisition ID: 542220

 

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!


Job Segment: Medical Device, QA, Quality Assurance, Compliance, Regulatory Affairs, Healthcare, Quality, Technology, Legal

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