Position Details

Type Full-Time

Experience senior

Exp. Years 5+ years

Education Bachelor's degree, preferably in a scientific, engineering, or technical discipline

Category QA & Testing

About this role

Principal Product Complaint Analyst leads quality initiatives to improve product quality and regulatory reporting across markets; collaborates cross-functionally to resolve complaints and drive CAPA and process improvements.

Key Responsibilities

Understand and ensure compliance with US and OUS regulatory requirements for medical devices; lead large post-market quality projects; coordinate multi-site stakeholders; communicate to senior leadership; support and implement new SOPs and WIs

Technical Overview

Role emphasizes regulatory compliance, complaint handling, and post-market vigilance; requires data analytics with SAS/Snowflake/Power BI and MS Office tools to drive decisions.

Ideal Candidate

Senior product quality analyst with 5+ years in medical devices/pharma; strong CAPA, post-market experience, and regulatory reporting proficiency; proficient in SAS/Snowflake/Power BI and MS Office; hybrid work willingness.

Must-Have Skills

Bachelor's degreepreferably in a scientificengineeringor technical disciplineMinimum of 5 years of medical device industrypharmaceuticalor diagnostic device experienceDemonstrated ability to understandshift and contribute to changing prioritiesCompetency of Microsoft Office Suite (i.e.WordXcelPowerPointVisioetc.)Working knowledge and practical implementation of FDAISOMDR regulations within the medical device industryDemonstrated proficiency in project management

Nice-to-Have Skills

Post Market activities - complaints and vigilanceCAPA experienceSASSnowflake or similar querying/analytic software experience

Tools & Platforms

Microsoft Office 365Power BISASSnowflake

Required Skills

Bachelor's degree; 5+ years medical device/pharma experience; FDA/ISO/MDR knowledge; Microsoft Office Suite; project management; CAPA; SOP; post market; regulatory reporting

Hard Skills

FDAISOMDRSOPCAPAPower BISASSnowflakeMicrosoft Office SuiteVisio

Soft Skills

leadershipcommunicationpresentationindependenceproblem-solving

Industry & Role

Industry Healthcare & Medical

Job Function Lead global post-market quality and regulatory reporting initiatives for medical devices

Role Subtype Senior Quality Analyst

Tech Domains Power BI, Microsoft Office 365, SAS, Snowflake

Keywords for Your Resume

principal product complaint analystmedical devicepharmaceuticaldiagnostic deviceFDAISOMDRCAPApost marketSOPSASSnowflakePower BIMicrosoft Office 365Visioauditregulatory reportingregulatory complianceproject managementquality

Deal Breakers

Bachelor's degree in a relevant scientific/engineering field, 5+ years medical device/pharma experience

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