Quality Assurance Technician - Complaints

Enovis; Austin (TX); On-site; USD 40,000 - 60,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401(k) Plan

Job summary

A medical technology company in Austin, TX is seeking a Quality Assurance Technician - Complaints to investigate medical device complaints and ensure compliance with quality system regulations. The ideal candidate has a high school diploma, 3 years of experience in a related field, and strong communication skills. This role involves working with returned devices and compiling data for quality metrics.

Qualifications

• 3 years related experience in a quality assurance role.
• Background in medical device or other highly regulated industry.
• Knowledge of ISO 13485 preferred.

Responsibilities

• Investigate and evaluate medical device complaints.
• Ensure proper documentation of returned devices.
• Write effective reports.

Skills

Detail oriented

Strong verbal communication

Strong written communication

Analytical skills

Proficiency in Microsoft Excel

Proficiency in Microsoft PowerPoint

Education

High School Diploma

Job description

Quality Assurance Technician - Complaints

About Enovis: Enovis Corporation (NYSE: ENOV) is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows.

Job Title: Quality Assurance Technician - Complaints
Reports To: Design Quality Engineering Manager
Location: Austin, TX

Job Summary: Investigates and evaluates medical device complaints, assists QA personnel with activities intended to assure compliance with quality system regulations, and to support new product and operations initiatives.

Key Responsibilities:

• Work with used, contaminated medical devices.
• Ensure proper documentation and registration of returned complaint devices.
• Write effective reports on returned devices.
• Basic trouble shooting and root cause analysis.
• Effectively and professionally communicate with internal and external customers.
• Work closely with Quality Engineers to aid in the investigation process of returned devices.
• Compile data for metrics and create reports/graphs.
• Assist the Quality Assurance/Quality Engineering team with projects and ensure compliance.

Minimum Basic Qualifications:

• High School Diploma
• Minimum 3 years related experience and/or training
• Background in medical device or other highly regulated industry required; preferred knowledge of ISO 13485
• Detail oriented and analytical
• Strong verbal and written communication skills
• Proficiency in Microsoft Excel and PowerPoint

Physical Requirements:

• Prolonged periods of sitting at a desk and working on a computer.
• Must be able to lift up to 30 pounds at times.

Desired Characteristics:

• Knowledge of mechanical inspection techniques and inspection equipment preferred

We Offer a Comprehensive Benefits Package Which Includes:

• Medical Insurance
• Dental Insurance
• Vision Insurance
• Spending and Savings Accounts
• 401(k) Plan
• Vacation, Sick Leave, and Holidays
• Income Protection Plans
• Discounted Insurance Rates
• Legal Services

Enovis provides equal employment opportunities based on merit, experience, and other work-related criteria and without regard to race, color, ethnicity, religion, national origin, sex, age, pregnancy, disability, veteran status, or any other status protected by applicable law.