Post Market Quality Technician

Post Market Quality Technician

This position plays an integral role in the Quality Department as a hands-on engineering role conducting post market investigations of FDA approved medical devices. The position requires organization skills, attention to detail, ability to work in cross functional teams, and drive to accomplish departmental and company goals. The shift start time is between 6 AM and 8 AM EST.

Key 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, NCR, and CAPA.
• Perform product testing and failure analysis.
• Review Lot Acceptance records and DHRs.
• Collect log quality data and trend results.
• Ensure accountability for quality data entry and productivity.
• Assist in gathering information during FDA and ISO 13485 inspections.
• Troubleshoot new failure modes.
• Evaluate process and engineering controls to improve safety and efficiency.
• Perform other duties as assigned.

Required Qualifications

Education: Associates Degree in an engineering or scientific discipline.

Preferred Qualifications

• An electrical and mechanical background is preferred.
• Prior experience working in a regulated industry, such as medical device, and/or experience working in a bio-hazard or lab environment is preferred.
• Two years of experience in a Quality related function, working with QSR and/or ISO 13485 is preferred.
• Computer proficiency in MS Office, specifically Excel, is needed. Experience creating and analyzing charts and Pareto charts is a plus.
• Ability to organize and complete tasks with minimal supervision.
• Technical writing skills are required.
• Experience with generating and maintaining organized and accurate records.
• Experience with Lean Six Sigma methodology is a plus.

This position requires on-site working arrangements in an office, plant, or lab environment. Physical requirements include sitting for 70% of the time and standing for 30%. This role involves frequent lifting of under 5 lbs and occasional handling (push/pull) of up to 50 lbs. The ability to operate basic hand tools is necessary.