Post Market Engineer Position Available In Alachua, Florida
Tallo's Job Summary: The Post Market Engineer role involves applying engineering problem-solving techniques for complaint investigation activities, conducting product analysis, root cause analysis, and risk analysis. The job requires a Bachelor's Degree in Engineering, understanding of FDA regulations, and experience in Medical Device or Pharmaceutical FDA-regulated environments. Strong communication, attention to detail, and organizational skills are essential for this role.
Job Description
Essential Responsibilities & Key Deliverables:
Applies sound engineering problem-solving techniques during complaint investigation activities. Performs complaint product analysis and testing per company procedures and requirements. Conducts complaint root cause analysis and supports conclusions with objective evidence and sound rationale. Completes complaint risk analysis and complaint history reviews. Escalates complaint investigation findings as appropriate and in accordance with internal procedures and requirements. Documents all complaint investigation, coding, and escalation activities per internal procedures. Coordinates the initiation of new complaints and regulatory reporting, as determined during investigations. Supports the completion of complaint activities in line with department metrics and key performance indicators. Applies knowledge of the company’s Quality System requirements and relevant FDA and international standards. Assists and supports other elements of the complaint handling process as directed.
Required Education, Experience, Skills, Credentials and Knowledge Education:
Bachelor’s Degree in an Engineering discipline from an accredited institution required.
Experience:
Understanding of root cause and risk analysis, as well as technical writing, required. Previous experience in a Medical Device or Pharmaceutical FDA-regulated environment is required; experience in product complaint investigation and handling preferred. Familiarity with FDA/ISO quality management system regulations.
Skills, Credentials, Knowledge:
Strong verbal and written communication skills. Excellent interpersonal skills; able to work effectively in a team environment. High attention to detail; consistently meets high standards of input accuracy and document quality. Strong organizational and time management abilities. Self-motivated; capable of setting priorities and working independently to meet deadlines. Proficiency with Microsoft Office and other relevant software applications. We are an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
