Validation Quality Technician

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 ISO14971 throughout the design transfer to manufacturing process as well as product lifecycle. He/she is responsible for maintaining strong Quality Records in compliance with Good Documentation Practices (GDP). He/she 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, 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 English language to be able to read documentation, communicate, and write.

• Ideal candidate will have keen eye for quality, is dependable, and will 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.