Senior Product Complaint Analyst

Boston Scientific • Santa Clarita, CA

8d • $71,500 - $135,800 • 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 working with cross-functional partners to address complex product quality and performance issues across global markets. The role uses clinical knowledge and data-driven analysis to evaluate complaint events, assess regulatory reportability and patient-safety impacts, support investigations, and inform decisions that contribute to quality, compliance and improved healthcare outcomes.

The position is hybrid, with employees expected to work at an assigned Boston Scientific facility at least three days per week. Boston Scientific does not offer employment-visa sponsorship or relocation assistance for this position.

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 applications, 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 positively influence team culture.
• Ensure compliance with U.S. and international regulatory requirements for medical-device complaint handling and regulatory reporting.
• Review complaint communications and assess regulatory compliance, reportability, and potential effects 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, Design Failure Mode and Effects Analysis (DFMEA), reported event information, investigation findings and regulatory decision models.
• Code complaint events to support product-performance records and collaborate with engineering, laboratory and other internal teams to review coding and investigation outcomes.
• Prepare clear, comprehensive written 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 products, 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 principles to identify process improvements, mitigate risk and enhance quality-system effectiveness.
• Support organizational training and knowledge-sharing activities.
• Identify and appropriately escalate risks, respectfully challenge assumptions 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.

Benefits

• Core and optional employee benefits are offered; the posting refers candidates to www.bscbenefitsconnect.com for details.
• Annual bonus targets and long-term incentives may be available to eligible exempt, non-sales employees, subject to plan eligibility and other requirements.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior