Post Market Quality Technician / Pay rate: $32/hr

Job Description

Job Description

Title: Post Market Quality Technician

Location: 100 Nagog Park, Acton Massachusetts 01720

Shift: Shift Start Time between 6 - 8 am EST

Pay rate: $32/hr on W2.

Job Summary:

• The Post Market Quality Technician plays an integral role in Client 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, 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

·         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