EMEA Senior Quality System Specialist
Location
Voisins le Bretonneux, Yvelines | France
Job description
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.
EMEA: Europe, Middle East and Africa
The Magellan Program is a value-driven transformational program focused on standardizing and modernizing many of our business processes through the implementation of SAP 4/HANA. A key component of the Magellan program will be the transition from ECC to SAP 4/HANA. Magellan program is executed in phases using agile principles and processes with real user input.
You start with 18 months temporary contract
About the role of EMEA Senior Quality System Specialist :
The Sr Quality System Specialist position has become available due to existing team focus on key activities on Magellan Program implementation within EMEA region. This position will support the team on Production and Process Control daily activities and, occasionally, Magellan program aspects as needed. The role will serve as a Quality representative to improve awareness, visibility, and communication on quality initiatives to support departmental, functional, site, regional, divisional, and corporate quality goals, and priorities. Develops, establishes, and maintains quality methodologies, systems, and practices which meet Boston Scientific, customer, and regulatory requirements. Collaborates with Quality management to recommend, design and implement functional process improvements. Specifically, this role will support Quality and business initiatives, ensuring compliance to Medical Device regulations and Boston Scientific Quality System requirements with a continuous improvement mindset.
Key to their success will be their ability to develop, establish and maintain quality processes which meet Boston Scientific, customer, and regulatory requirements.
Hybrid / Remote. The successful candidate should ideally be located close to an EMEA Boston Scientific Hub / Office (Madrid, Paris, Dusseldorf, London, Milan, Warsaw or Kerkrade) and be available to travel, as needed, within the Region to attend key internal meetings (likely, no more than once per Quarter)
Your key responsibilities will include:
-Supports EMEA Business Projects / Initiatives for specific areas of responsibility, within Finished Good Acceptance, Handling and Distribution controls, Quality System sub process including Field Inventory Management & Distribution Controls
-Supports Global Continuous Improvement Initiatives representing EMEA interests.
-Provides functional support, as a SME for specific areas of responsibility, at Country and Regional level.
-Provides project direction, coaching, and mentoring for engineering and technical team personnel.
-Proactively investigates, identifies, and implements best-in-class Quality System Processes and practices.
-Apply effective, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
-Supports Global Value Improvement Program.
-Assure the development and execution of streamlined business systems, which effectively identify and resolve quality issues.
-Advise management on potential improvements or enhancement to quality systems and processes.
-Documents audit non-conformances, evaluates impact, and makes recommendations for corrective actions, ensuring good recording and administration and timely closure of all related NCEP or CAPA activities/actions.
-Communicates non-conformances to owners, managers, directors, and upper management.
-Supports departmental, functional, divisional, and corporate quality goals and priorities.
-Act as leader or team member in supporting quality disciplines, decisions, and practices.
-Builds quality into all aspects of work by maintaining compliance to all quality requirements.
-Collaborates and Participates on CAPA and Lean Business project teams as appropriate.
-Support the team as needed on Magellan Program implementation within EMEA focus on Production and Process Control processes assessing potential impact on active projects, regional/local document updates, training, Business change impacts.
Who we are looking for:
-Bachelor’s degree
-Experience working in medical device (or related) industry required.
-5-7 Years of experience required; Relevant functional experience within the areas of Distribution/Field Inventory management preferred.
-Demonstrated capability in collaborating and partnering within a global environment/ matrix organization.
-Experience working in cross-functional teams.
-Proven track record in building a continuous improvement culture based on Business Excellence principles and methodologies.
-Ability to work independently and as a member of a team in a dynamic environment.
-Demonstrated high degree of integrity, professionalism, and ability to establish credibility.
-Strong interpersonal communication, collaboration and influencing skills.
-Strong decision-making skills. Focus on prioritization linked to risk management, problem solving and time management skills
-High sense of urgency and commitment to execution in a dynamic environment
Requisition ID: 576583
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 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 and look forward to connecting with you!
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