Senior Quality System Specialist (maternity leave)

<p>Additional Locations: Netherlands-Kerkrade; Ireland-Galway; Spain-Madrid</p> <p>Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance</p> <p>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.</p> <p> </p> <p>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.  <br/>  <br/> Remote Eligible: Hybrid <br/> Onsite Location(s): Kerkrade, Netherlands or Galway, Ireland or Madrid, Spain</p> <p> </p> <p><u>About the Role:</u><br/> The Senior Quality Systems Specialist will provide Quality Systems support to the Europe, Middle East and Africa (EMEA) region.  The Quality Systems team is responsible for full quality system oversight and specific functional responsibilities (Management Controls, Training, Audits, Supplier Management, Document and Records Control, and NCEP/CAPA) for Boston Scientific.</p> <p> </p> <p>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.<br/>  <br/> <u>Your responsibilities include:</u></p> <ul> <li>Implement, maintain, and improve the EMEA Quality Management System.</li> <li>Responsible for working with QA management, department personnel and other areas on process reviews and implementation of requirements in compliance programs.</li> <li>Ensures Annual Global Quality Systems Objectives and Metrics are understood and achieved in line with BSC Best4 Quality Strategy and report metrics related at regional level</li> <li>Act as CAPA coordinator to monitor timely completion of NCEP and CAPA phases, provide support to NCEP owners, act as mentor to CAPA owners and actively participate in CAPA team meetings.</li> <li>Prepare material for and conduct regularly scheduled CAPA Review Board meetings.</li> <li>Plan and conduct scheduled internal audits to assess compliance with FDA, ISO, MDR, and internal requirements.  </li> <li>Plan and conduct supplier and 3PL assessments.</li> <li>Support site level internal/external audits  acting as Subject Matter Expert (SME).</li> <li>Provide functional support as an SME as applicable to internal &amp; external functions.</li> <li>Act as a coach/ mentor to aid development of junior staff members.</li> <li>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).</li> <li>Act as team/cross-functional team member/lead in supporting quality disciplines, decisions, and practices both internally &amp; externally.</li> <li>Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.</li> <li>Collaborate with cross-functional colleagues regarding the impacts of enhancements and process changes. </li> <li>Execute the testing and training development for future rollouts of business applications.</li> <li>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</li> <li>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.</li> </ul> <p> <br/> <u>What we are looking for:</u></p> <ul> <li>5+ Years relevant experience in the Medical Device, Pharma or Food environment</li> <li>Experience with nonconformance and CAPA investigation tools</li> <li>Green Belt certified (is a plus) with process management experience</li> <li>Nonconformance/CAPA and Quality Systems experience required</li> <li>Familiar with quality tools and problem-solving techniques</li> <li>Team player with strong work ethic and positive me