Boston Scientific Senior Quality Assurance Engineer 

United States, Massachusetts, Marlborough 

142885956

This role provides support to the Global Post Market team by leading integrations of companies acquired by Boston Scientific into Boston Scientific’s Post Market system(s) and processes, as well as supporting various projects resulting from regulation changes, business requirements or CAPAs. 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.
Your Responsibilities Will Include:

• Providing project management, including management of project teams and supporting quality system documentation, for Post Market projects
• Coordinating parallel tasks and meetings to drive collaboration of multi-site and multi-functional stakeholders to support project deliverables and timelines
• Leading Post Market workstream for acquisition integration projects
• Ensuring compliance to US & OUS regulatory requirements
• Collaborating with Post Market sites and teams
• Providing audit support (backroom and storyboard preparation)
• Collaborating with local and international Regulatory and Quality as required
• Supporting and implementing new SOPs, WIs, and/or KSDs to improve and/or standardize Post Market processes
• Supporting updates to impacted SOPs/WI
• Identifying and ensuring training needs are addressed for Post Market requirements
• Effectively identifying and escalating risks and working to resolve issues
• Working independently across the organization
• Participating in the Global Post Market Community
• In all actions, demonstrating a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
• Traveling to support projects, as required

What We're Looking For In You:
Required Qualifications

• Bachelor’s degree, preferably in a scientific or technical discipline.
• Minimum of 4+ years of medical device industry experience
• Comprehensive understanding and working knowledge of Trackwise and/or SAS applications
• Effective 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 quality
• Strong research, communication, and presentation skills
• Effective written and oral communication, technical writing, and editing skills
• Travel approximately <5% of the time

Preferred Qualifications

• Detailed understanding and working knowledge of US and International regulations including 21 CFR, 820, 210, 211, and 11 is required, as well as the Medical Device Directive, EN ISO 13485, EN ISO 14971, IEC 60601, and EN 62366.
• Project Management Skills and Ability to manage multiple small projects.
• CAPA experience.
• Ability to work independently with minimal supervision
• Agile/Scrum experience
  

Among other requirements, Boston Scientific maintains specific prohibited substance testing requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement. The goal of the drug testing is to increase workplace safety in compliance with the applicable law.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.