QA Technician

Location: On-site, Middleton, WI

SUMMARY:

The Quality Technician you 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. 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.

• 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.
• 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.
• Conduct incoming inspection to ensure product is compliant with specifications.
• Responsible for assisting 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.

Travel Required: Minimal, less than 5%.

Knowledge, Skills, and Abilities necessary to perform essential functions:

• 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

Education and/or Experience

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.

Certificates, Licenses, Registrations

ASQ certification a plus