Apply on Employer Site

Boston Scientific · 1 day ago

Senior QA Engineer

Maple Grove, MN

Full-time

Hybrid

Mid, Senior Level

$83K/yr - $157K/yr

4+ years exp

Boston Scientific is a leader in medical science, dedicated to solving significant health industry challenges. The Senior QA Engineer will support global quality goals by managing post-market quality initiatives and ensuring compliance with regulatory requirements while collaborating with various teams.

Health CareMedicalMedical Device

No H1B

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

Qualification

Medical Device ExperienceQuality System DocumentationProject ManagementFDA Regulations KnowledgeStatistical Analysis ToolsCAPA ExperienceAgile/Scrum ExperienceAnalytical SkillsEffective Communication

Required

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

Preferred

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