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Boston Scientific · 1 day ago

Principal Product Complaint Analyst

Marlborough, MA

Full-time

Hybrid

Senior Level, Lead/Staff

$107K/yr - $203K/yr

8+ years exp

Boston Scientific is a leader in medical science focused on transforming lives through innovative medical solutions. The Principal Product Complaint Analyst will lead strategic initiatives to enhance product quality and performance, collaborating with cross-functional teams to address complex challenges in the medical device industry.

Health CareMedicalMedical Device

No H1B

Responsibilities

Understanding and ensuring compliance with US and 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

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

Influencing change and aligning stakeholders to make decisions with limited information

Providing audit support in the front room and back room

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

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

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

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

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 with the Quality Policy and all other documented quality processes and procedures

Traveling as required

Qualification

Medical device experienceFDA regulationsISO regulationsProject managementData analyticsMicrosoft Office SuiteSASSnowflakeTechnical writingCommunication skills