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Boston Scientific · 1 week ago

Principal Product Complaint Analyst

Santa Clarita, CA

Full-time

Hybrid

Senior Level, Lead/Staff

$104K/yr - $197K/yr

8+ years exp

Boston Scientific is a leader in medical science committed to solving critical health industry challenges. The Principal Product Complaint Analyst will lead strategic initiatives aimed at enhancing product quality and performance, ensuring compliance with regulatory requirements, and utilizing data-driven insights to improve processes in the medical device industry.

Health CareMedicalMedical Device

No H1B

Responsibilities

Consistent, positive influence on the culture of the team, setting an example as a leader of high-quality work, effective communication, dealing with adversity, and solution-oriented thinking

Understanding and ensuring compliance to US & OUS regulatory requirements for medical devices for complaint handling and regulatory reporting

Participating in the Global Quality Community to lead large, highly impactful projects to improve post market quality across multiple divisions

Utilizing data and analytics to identify areas of risk, opportunities and priorities

Coordinating parallel tasks and meetings to drive collaboration of multi-site and multi-functional stakeholders to support project deliverables and timelines

Providing and presenting succinct, clear communication to senior leadership on deliverables, timelines and milestones

Influence change and align stakeholders to make decisions with limited information

Supporting and implementing new Standard Operating Procedures and Work Instructions to improve and/or standardize complaint and regulatory reporting processes

Apply systems-thinking to a complex quality system to streamline and identify areas for improvement and identify areas of risk and provide and manage plans for improvement

Providing audit support in the frontroom and backroom

Effectively identifying and escalating risks, respectfully challenging management and status quo where appropriate, providing recommendations and working to resolve issues

Working independently across the organization

In all actions, demonstrating a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures

Traveling as required

Qualification

Medical device experienceFDA regulations knowledgeProject management proficiencyData analytics skillsCAPA experienceMicrosoft Office SuiteResearch skillsEditing skillsSASSnowflake experienceEffective communicationTechnical writingProblem-solvingTeam collaborationIndependent workPresentation skills