QA Complaint Analyst III

Werfen North America; Bedford (MA); On-site; USD 60,000 - 90,000; Full time

Job summary

An established industry player in medical equipment manufacturing is seeking a QA Complaint Analyst III to join their team. This role involves performing in-depth analyses of complaints and failures across product lines, utilizing scientific methods and problem-solving techniques. You will communicate findings, schedule investigative activities, and contribute to compliance with FDA and ISO standards. The ideal candidate will have strong analytical and communication skills, with a Bachelor's degree and five years of relevant experience. Join a collaborative environment where your expertise will help drive quality assurance and enhance product reliability.

Qualifications

• Minimum 5 years of relevant experience in quality assurance.
• Strong understanding of FDA and ISO standards.

Responsibilities

• Perform complaint and failure analyses for assigned product lines.
• Conduct complex investigations and prepare accurate reports.

Skills

Analytical Skills

Communication Skills

Problem Solving

Statistical Analysis

Education

Bachelor's Degree in a Related Field

Tools

MS Office

Job description

Join to apply for the QA Complaint Analyst III role at Werfen North America.

Get AI-powered advice on this job and more exclusive features.

Position Summary

Performs a wide range of complaint and failure analyses for all assigned product lines, requiring application of logic, understanding of general and specialized laboratory methods, techniques, and instruments. May coordinate the activities of others as assigned. May assist others in reviewing closures written by QA Complaint Analyst I or II.

Responsibilities

Key Accountabilities

• Understand the application of the scientific method to experimental design and problem solving. Investigate and understand complaint information.
• Communicate results, problems, and progress to supervisor.
• Schedule investigative activities based on assignments and priorities.
• Detect problems in routine procedures caused by instrument difficulties or reagent handling, and suggest modifications.
• Perform stability monitoring testing, analyze data, and prepare reports.
• Handle broad assignments involving multiple tasks, applying experimental design principles.
• Conduct complex investigations, provide assessments, and write accurate reports in a timely manner.
• Perform other related duties as assigned.

Secondary Functions

• Contribute to department goals and be a team player.
• Understand FDA, ISO, and worldwide standards for complaint system compliance.
• Enhance professional judgment through training and literature review.

Qualifications

Minimum Knowledge & Experience:

• Bachelor's degree in a related field.
• Five years of relevant experience.

Additional Skills & Capabilities:

• Proficiency in MS Office and knowledge of basic statistics.
• Strong communication skills and ability to interact with various groups.

Travel Requirements

N/A

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Quality Assurance

Industries

Medical Equipment Manufacturing