
Post Market Quality Technician
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Overview
Job Description
Job Description:Post Market Quality TechnicianShift Start Time between 6 - 8 am EST
The Post Market Quality Technician plays an integral role ins Quality Department as a hands-on engineering role conducting post market investigations of FDA approved medical devices. The position requires strong organization skills, attention to detail, ability to work in cross functional teams, and drive to accomplish departmental and company goals.
Responsibilities:Perform moderately complex tasks to ensure compliance with quality standardsPartner with quality assurance engineers and other team members to ensure effective inspection and testing procedures are implemented and maintainedGenerate, review and maintain Quality records in support of the Quality System, e.G., training, internal audits, Client, and CAPAPerform product testing and failure analysisReview Lot Acceptance records and DHRsCollect log quality data and trend resultsAccountability for quality data entry and productivityAssist in gathering information during FDA and ISO 13485 inspectionsTrouble shoot new failure modes.Evaluate process and engineering controls to improve safety and efficiency.Perform other duties as assigned.
Education and Experience:Minimum Requirements:Associates Degree in an engineering, or scientific disciplinePreferred Skills and Competencies:Electrical and mechanical background strongly preferredPrior experience working in a regulated industry (medical device) and/or experience working in a bio-hazard/lab environment preferredPreferred 2 years in a Quality related function, working with QSR and/or ISO 13485Computer proficiency in MS office (specifically Excel);experience creating and analyzing charts and Pareto charts a plusAbility to organize and complete tasks with minimal supervisionExcellent technical writing skillsExcels at generating and maintaining organized and accurate recordsExperience with Lean Six Sigma methodology a plus
Physical Requirements (if applicable):Sitting 70%, Standing 30%Frequent lifting <5lbsOccasional (<10% of time) handling (push/pull) up to 50lbsAbility to operate basic hand toolsNOTE: This position requires on-site working arrangements (requires on-site office/plant/lab work).
Start Date - End Date: Jun 22 Sep 19, 2026
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