Post Market Quality Technician

Job Description:
Post Market Quality Technician
Shift Start Time between 6 - 8 am EST

Overview:
The Post Market Quality Technician plays an integral role in ***’s 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 standards
Partner with quality assurance engineers and other team members to ensure effective inspection and testing procedures are implemented and maintained
Generate, review and maintain Quality records in support of the Quality System, e.G., training, internal audits, Client, and CAPA
Perform product testing and failure analysis
Review Lot Acceptance records and DHRs
Collect log quality data and trend results
Accountability for quality data entry and productivity
Assist in gathering information during FDA and ISO 13485 inspections
Trouble 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 discipline

Preferred Skills and Competencies:
Electrical and mechanical background strongly preferred
Prior experience working in a regulated industry (medical device) and/or experience working in a bio-hazard/lab environment preferred
Preferred 2 years in a Quality related function, working with QSR and/or ISO 13485
Computer proficiency in MS office (specifically Excel);experience creating and analyzing charts and Pareto charts a plus
Ability to organize and complete tasks with minimal supervision
Excellent technical writing skills
Excels at generating and maintaining organized and accurate records
Experience with Lean Six Sigma methodology a plus
Physical Requirements (if applicable):
Sitting 70%, Standing 30%
Frequent lifting <5lbs
Occasional (<10% of time) handling (push/pull) up to 50lbs
Ability to operate basic hand tools
NOTE: This position requires on-site working arrangements (requires on-site office/plant/lab work).

Start Date - End Date: Sep 14 –Dec 12, 2026