Post market quality technician

Job Title:
Post Market Quality Technician

Location:
Acton, MA

Pay range: $30 - $32

Duration: 3+ MONTHS

Shift Start Time between 6 - 8 am EST

The Post Market Quality Technician plays an integral role in 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.

• 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
• Accountability for quality data entry and productivity
• Assist in gathering information during FDA and ISO 13485 inspections
• Evaluate process and engineering controls to improve safety and efficiency.
• Perform other duties as assigned.

• Associates Degree in an engineering, or scientific discipline

• 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

• Sitting 70%, Standing 30%
• Occasional (