QA Post Market Engineer Job Gainesville area,Florida USA,Engineering

Position: QA Post Market Engineer (All Levels)
QA Post Market Engineer (All Levels)

Department: Quality

Employment Type: Full Time

Location: Gainesville, FL

Reporting To: Director Post Market Surveillance

Description

The QA Post Market Engineer supports post-market surveillance activities by performing product complaint investigations, root cause analysis, and product evaluations. This role plays a key part in ensuring compliance with regulatory requirements, driving continuous improvement, and maintaining the quality and safety of products in the field.

Key Responsibilities

Conduct complaint investigations, including product analysis, testing, and root cause determination in accordance with company procedures
Apply sound engineering principles and problem-solving techniques to evaluate product issues
Perform risk assessments and complaint trend/history reviews
Escalate findings appropriately and collaborate with cross-functional teams to ensure thorough investigations
Document all investigation activities in compliance with internal procedures and regulatory standards
Support ongoing product improvement efforts for orthopedic implants and instruments
Assist with quality system processes, including CAPAs, HHEs, and NCRs
Contribute to meeting departmental metrics and performance goals
Support internal and external audits related to complaint handling
Draft investigation summaries and responses for customers, as needed
Assist in developing and updating procedures, work instructions, and technical documentation
Participate in continuous improvement initiatives and team training efforts
Ensure adherence to the company Quality System and applicable FDA/ISO regulations

Skills Knowledge and Expertise

Education:

Bachelor's degree in Engineering required (Mechanical or Biomedical preferred);
Master's degree a plus

Experience:

Foundational knowledge of engineering principles such as mechanical design, GD&T, CAD, materials, and analysis methods
Experience or exposure to root cause analysis, risk assessment, and technical documentation
Prior experience in a medical device or FDA-regulated environment preferred
Familiarity with FDA/ISO quality systems preferred

Functional/Technical Knowledge,

Skills and Abilities

Required:

Strong written and verbal communication skills
Detail-oriented with a high level of accuracy in data analysis and documentation
Excellent organizational and time management skills
Ability to work both independently and collaboratively in a team environment
Problem-solving mindset with the ability to apply technical principles creatively
Proficiency in Microsoft Office applications