QA Technician/Quality Controller-Entry Level

Natus Neuro•Middleton, WI

20d•Onsite

About The Position

The Quality Technician will ensure compliance with medical device quality and regulatory standards by performing incoming inspections, maintaining Device History Records (DHRs), and managing quality documentation in accordance with FDA, ISO 13485, and cGMP requirements. This role partners closely with Production and Warehouse teams to inspect and verify incoming materials and finished products, support nonconforming material processes, and drive quality and continuous improvement initiatives. The technician must stay up-to-date and follow all Quality System procedures related to this job, which can affect the quality of products or services provided to our customers. They will ensure Device History Records (DHR) comply with requirements per the current Good Manufacturing Practices (cGMP’s), including electronic DHRs. Activities include filing and retrieving DHR’s. The technician will conduct incoming inspection to ensure product is compliant with specifications and is responsible for assisting with off-site record retention and disposal. They will implement, coordinate, and assist with other projects as assigned including team participation. The role requires maintaining familiarity with appropriate regulations/standards relative to medical device design, engineering and distribution (i.e. ISO 13485, FDA Part 21 820, Medical Device Directive/Medical Device Regulation, etc.) and disseminating information as required. The technician will document and initiate corrective/preventive and effectiveness checks, when applicable, and assist with quality audits and quality processes and documentation improvements. Responsibilities include incoming materials, and the technician has the responsibility and authority for the acceptance or rejection of product that does not meet requirements. They are responsible for ensuring all operations conducted meet the requirements for quality, products, processes and records as required by the quality management system, and for adhering to the principles and requirements in the company’s quality policy and applicable Regulatory and Quality standards. Assisting with the Nonconforming material process and working overtime at the end of the month/quarter are also part of the role.

Requirements

Organizational skills
Familiarity with basic test equipment
Written and verbal communication skills
Process and product auditory skills
Ability to interface with all departments
Ability to work independently
Quality measurements and problem-solving skills
Demonstrate decision making skills
Ability to meet deadlines
Critical Thinking
Associate's degree (A.A.) or equivalent from a two-year college or technical school; or six months to one year related experience and/or training; or equivalent combination of education and experience.

Nice To Haves

ASQ certification a plus

Responsibilities

Perform incoming inspections
Maintain Device History Records (DHRs)
Manage quality documentation
Inspect and verify incoming materials and finished products
Support nonconforming material processes
Drive quality and continuous improvement initiatives
Ensure Device History Records (DHR) comply with requirements per the current Good Manufacturing Practices (cGMP’s), including electronic DHRs
File and retrieve DHR’s
Conduct incoming inspection to ensure product is compliant with specifications
Assist with off-site record retention and disposal
Implement, coordinate, and assist with other projects as assigned including team participation
Maintain familiarity with appropriate regulations/standards relative to medical device design, engineering and distribution (i.e. ISO 13485, FDA Part 21 820, Medical Device Directive/Medical Device Regulation, etc.)
Disseminate information as required
Document and initiate corrective/preventive and effectiveness checks, when applicable
Assist with quality audits as applicable
Assist with quality processes and documentation improvements
Responsible for incoming materials
Have the responsibility and authority for the acceptance or rejection of product that does not meet requirements
Responsible for ensuring all operations conducted meet the requirements for quality, products, processes and records as required by the quality management system
Responsible for adhering to the principles and requirements in the company’s quality policy
Responsible for adhering to the applicable Regulatory and Quality standards
Assisting with the Nonconforming material process
Work overtime at the end of the month/quarter