Quality Technician - 4+months contract - $30/hr on w2

Lancesoft INC

Acton, MA, USA

Published: 6/14/2022

Technology

Full Time

Job Description

Title: Quality Technician

Contract duration 04+months

Pay: $30/hr on w2

Position Overview

The Quality Technician is responsible for executing Test Method Validations, Process Validations, and other engineering studies in accordance with written protocols and procedures to maintain the validated state of Insulet’s product manufacturing and quality processes.

The Quality Technician collaborates with Quality Engineering to ensure new and existing products conform to the Insulet Quality System, Quality System Regulation, ISO 13485, and ISO 14971 throughout the design transfer to manufacturing process as well as the product lifecycle.

Responsible for maintaining strong Quality Records in compliance with Good Documentation Practices (GDP).

Will serve as a Quality representative on wide-scale remediation efforts to ensure compliance to both internal and external requirements in areas including process risk management, test method validation, and process validation.

Responsibilities

Follow validation and verification protocols to execute engineering studies, process validation, test method validation (Gage R&R and Attribute Agreement Analysis), and process verification studies.
Enter and maintain data in compliance with internal and external Quality Records requirements, following Good Documentation Practices (GDP).
Excellent attention to detail, good organization, and capable of working independently with minimal instruction from production supervisor.
Able to work in small groups and cross-functional teams to troubleshoot issues, identify, and implement collective corrective actions.
Performs other duties as required.

Education and Experience

High School Diploma or GED.
Experience in Quality in an FDA regulated industry.
Experience with performing test method validation and process validation of medical device products.
Experience with word processing, spreadsheet, and database programs.

Skills and Competencies

Self-starter capable of dealing with a variety of tasks in a fast-paced, multi-tasking environment.
Must be proficient in the English language to be able to read documentation, communicate, and write.
Ideal candidate will have a keen eye for quality, be dependable, work collaboratively within a team, and possess a positive attitude.
Previous experience working in a clean room environment.
Manufacturing and/or inspection experience in a regulated industry is a plus.
Knowledge of raw materials, measurement instruments, production processes, quality control, and other techniques for the manufacture/inspection of medical devices.
Recognizes problems and understands root cause analysis techniques/concepts.
Experience with ETO sterilization methods preferred.
Ability to generate and maintain accurate records.
Ability to follow up with task owners to close out open items.

\nCompany Description

LanceSoft is rated as one of the largest staffing firms in the US by SIA. Our mission is to establish global cross-culture human connections that further the careers of our employees and strengthen the businesses of our clients. We are driven to use the power of our global network to connect businesses with the right people, and people with the right businesses without bias. We provide Global Workforce Solutions with a human touch.