Senior QA Engineer

Additional Location(s): Costa Rica-Coyol; Ireland-Galway; US-CA-Valencia; US-MA-Marlborough; US-MN-Arden Hills; US-MN-Maple GroveDiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt 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 Senior QA Engineer supports global quality goals and priorities by maintaining and enhancing global systems and processes for the Post Market Quality organization. This role will be primarily responsible for providing leadership and support of global post market initiatives and operations including a focus on Project Guardian activities, partnership with Magellan, AI/automations, APAC processes/partnerships, CAPAs, quality management review, vigilance reporting (notified body, summary, worldwide), global post market data reporting and audits.This role requires strong project management skills, quality system documentation skills, and a proficient understanding of Post Market processes and requirements. Responsibilities may include leading Post Market project teams, identifying key project deliverables, setting appropriate timelines aligning with project milestones, working with cross-divisional/functional representatives to gather required information, communicating project status to senior leadership, and supporting Post Market process improvements and initiatives.Work mode:At Boston Scientific, we value collaboration and synergy. This hybrid role is based in Marlborough, MA, Valencia, CA, Maple Grove, MN or Arden Hills, MN and requires being on-site at least three days per week. We will also consider candidates based in our Galway, Ireland location or Coyol, Costa Rica.Relocation assistance:Relocation assistance is available for this position at this time.Visa sponsorship:Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.Your responsibilities will include:Providing project management, including management of project teams and supporting quality system documentation, for Post Market projectsCoordinating parallel tasks and meetings to drive collaboration of multi-site and multi-functional stakeholders to support project deliverables and timelinesEnsuring compliance with US & OUS regulatory requirementsCollaborating with Post Market sites and teamsProviding audit support (backroom and storyboard preparation)Collaborating with local and international Regulatory and Quality as requiredSupporting and implementing new SOPs, WIs, and/or KSDs to improve and/or standardize Post Market processesIdentifying and ensuring training needs are addressed for Post Market requirementsEffectively identifying and escalating risks and working to resolve issuesWorking independently across the organizationParticipating in the Global Post Market CommunityIn all actions, demonstrating a primary commitment to patient safety and product quality by maintaining compliance with the Quality Policy and all other documented quality processes and procedures.Traveling as required to support projects, as requiredWhat we're looking for in you:Required QualificationsBachelor's degree, preferably in a scientific or technical discipline.Minimum of 4+ years of medical device industry experienceEffective research and analytical skills.Competency of Microsoft Office Suite (i.e., Word, Xcel, PowerPoint, Visio, etc.), and Statistical Analysis tools (or equivalent).Working knowledge of FDA, ISO, MDD and the medical device industry qualityStrong research, communication and presentation skillsEffective written and oral communication, technical writing, and editing skillsTravel approximately