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Principal Product Complaint Analyst at Boston Scientific Corporation Malaysia

Georgetown, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

14 Apr, 26

Salary

0.0

Posted On

14 Jan, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Complaint Reporting, Regulatory Reporting, Quality System, Project Management, Microsoft Office Suite, FDA Regulations, ISO Regulations, MDR Regulations, CAPA, Research Skills, Communication Skills, Technical Writing, Analytic Software, SAS, Snowflake, Risk Management

Industry

Medical Equipment Manufacturing

Description

Your responsibilities will include: 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 Working independently across the organization Bachelor's degree, preferably in a scientific, engineering, or technical discipline Minimum of 8+ years of medical device industry experience Demonstrated ability to understand, shift and contribute to changing priorities Competency of Microsoft Office Suite (i.e., Word, Xcel, PowerPoint, Visio, etc.), Working knowledge and practical implementation of FDA, ISO, MDR regulations within the medical device industry Demonstrated proficiency in project management Travel approximately

Responsibilities

The Principal Product Complaint Analyst will support and implement new Standard Operating Procedures to enhance complaint and regulatory reporting processes. They will also apply systems-thinking to streamline quality systems and manage improvement plans.