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:

• Bachelors degree in Engineering required (Mechanical or Biomedical preferred); Masters 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