QA Post Market Engineer (All Levels)
Advita Ortho
QA Post Market Engineer (All Levels)
Advita Ortho
Posted 3 months ago
Full Time
Gainesville, Florida
In Person
Smart Summary
Responsibilities
The QA Post Market Engineer performs product complaint investigations and root cause analysis to ensure product safety and quality. This role involves conducting risk assessments and collaborating with cross-functional teams to drive continuous improvement for orthopedic implants.
Qualifications
You have a Bachelor's degree in Engineering (Mechanical or Biomedical preferred) and foundational knowledge of engineering principles. You possess experience or exposure to root cause analysis, risk assessment, and technical documentation, ideally within a medical device or FDA-regulated environment.
Must Have Skills for ATS
GD&T
CAD
root cause analysis
risk assessment
technical documentation
FDA regulations
ISO regulations
CAPAs
HHEs
NCRs
Job Description
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
- 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
- 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
Advita Ortho
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