Senior QA Engineer

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Additional Location(s): Costa Rica‑Coyol;
Ireland‑Galway; US‑CA‑Valencia; US‑MA‑Marlborough; US‑MN‑Arden Hills; US‑MN‑Maple Grove

Diversity – Innovation – Caring – Global Collaboration – Winning Spirit – High Performance

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, global post market data reporting and audits.

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 is not available for this position at this time.

Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

• 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

• 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, Excel, 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.

• Detailed understanding and working knowledge of US and International regulations including 21 CFR, 820, 210, 211, and 11 and 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.

Minimum Salary: $82,600
Maximum Salary: $156,900

Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. For non‑exempt hourly, non‑sales roles, variable compensation from time to time may be included. For exempt, non‑sales roles, variable compensation such as annual bonus target and long‑term incentives may be included.

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve…