Senior Product Complaint Analyst

Boston Scientific•Valencia, MN

7d•Hybrid

About The Position

The Senior Product Complaint Analyst is part of Boston Scientific’s Neuromodulation Division Complaint Management Center (CMC), analyzing customer complaints and collaborating with cross-functional partners to improve product quality and performance across global markets. The role evaluates regulatory compliance, reportability, patient-safety impacts, and business risks; conducts complaint investigations; and uses data-driven insights to inform decisions and process improvements. The position is hybrid, with employees expected to work at their assigned Boston Scientific facility at least three days per week. Boston Scientific will not provide visa sponsorship or relocation assistance for this position. The position is considered safety-sensitive and requires a prohibited-substance test.

Requirements

Bachelor’s degree in a scientific, technical, or related discipline.
At least 5 years of experience in the medical device industry.
Ability to adapt to changing priorities and contribute effectively in a dynamic environment.
Proficiency with Microsoft Office, including Word, Excel, and PowerPoint.
Working knowledge and practical application of FDA, ISO, and other applicable medical device regulations.

Nice To Haves

Experience supporting corrective and preventive action (CAPA) activities.
Experience handling complaints for neuromodulation or implantable medical device products.
Strong research, communication, and presentation skills.
Strong technical writing, editing, and documentation skills.
Ability to work independently with minimal direction or supervision.
Experience using data analytics to support quality, compliance, or business decision-making.
Proven ability to influence cross-functional stakeholders and drive process improvements.
Experience presenting recommendations and project updates to leadership audiences.

Responsibilities

Model high-quality work, effective communication, resilience, and solution-oriented thinking to support a positive team culture.
Ensure compliance with U.S. and international medical-device complaint-handling and regulatory-reporting requirements.
Review complaint communications and assess regulatory compliance, reportability, and potential impact on patient safety and business operations.
Apply clinical knowledge of product applications to evaluate complaints and conduct investigations, gathering information from clinical staff, field representatives, internal stakeholders, and laboratory analyses.
Make regulatory reportability decisions using hazard analyses, DFMEA, event information, investigation findings, and regulatory decision models.
Code complaint events to support product-performance records and collaborate with engineering, laboratory, and other teams on coding and investigation outcomes.
Write clear, comprehensive communications for physicians and other end-user customers describing clinical observations, investigations, product analyses, and corrective actions as applicable.
Support and lead divisional initiatives and strategic priorities.
Review peers’ work, provide constructive feedback, and identify process-improvement opportunities.
Use data and analytics to identify risks, opportunities, and business priorities.
Communicate and present deliverables, timelines, and milestones clearly to leadership.
Influence change and align stakeholders to support decisions when information is limited.
Apply systems thinking to identify process improvements, mitigate risk, and enhance quality-system effectiveness.
Support organizational training and knowledge-sharing activities.
Identify and escalate risks, respectfully challenge assumptions when appropriate, and recommend solutions.
Work independently and collaboratively across functions to achieve business objectives.
Maintain a primary commitment to patient safety and product quality by complying with the Quality Policy and documented quality processes and procedures.