Sr. QA Engineer

Recruiter: Spencer Gregory Hale

 

 

Senior QA Engineer

 

Role Description:

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. 

 

Responsibilities:

• 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
• Ensuring compliance with 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
• 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 with the Quality Policy and all other documented quality processes and procedures.
• Traveling as required to support projects, as required 

 

Qualifications:

Minimum Qualifications

• Bachelor’s degree, preferably in a scientific or technical discipline.
• Minimum of 4+ years of medical device industry experience
• 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

 

 

Requisition ID: 617889 

Minimum Salary: $ 82600 

Maximum Salary: $ 156900 

 

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com—will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among