QA Post Market Engineer (All Levels)
Advita Ortho
1 day ago
Full-time
On-site
Gainesville, Florida, United States
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