Job Title

Quality Inspector II

Requisition

JR000015113 Quality Inspector II (Open)

Location

Madison, WI

Additional Locations

Job Description Summary

Job Description

The Quality Inspector II is responsible for ensuring that materials, processes, activities, and environmental conditions involved in daily device manufacturing, processing, and packaging meet current Good Manufacturing Practice (GMP) standards and comply with applicable procedures and regulations. This role safeguards the quality and integrity of the product and ensures all work aligns with the company’s quality system and medical device regulatory requirements.

Essential Functions

Performs one of three functions in the Quality department:

Inspecting raw materials to meet production requirements

Conducts in-process inspection of manufacturing product and processes

Reviews final documentation and shipment packaging for medical devices, subassemblies, and kits

Collaborates with multiple departments to ensure all reviewed processes are executed in compliance with applicable standards.

Supports investigations by assisting Quality team members and other departments with root cause analysis.

Applies critical thinking to interpret specifications and confirm compliance with technical, cosmetic, and cleanliness requirements.

Demonstrates strong knowledge of Good Documentation Practices (GDP) and provides guidance to other departments as needed.

Conducts First Article Inspections and develops or revises incoming inspection plans, routing them for necessary approvals.

Provides support in the Madison Manufacturing documentation control room.

Accurately documents all activities, prepares and applies material quality status labeling, and ensures proper storage and handling of product and labeling in a secure, controlled environment.

Develops, implements, and maintains QA procedures, standards, and controls.

Assists with quality investigations for nonconformances and supports preventive action efforts within the QA unit.

Performs quality reviews for quarantine releases involving non-reportable, non-complaint, RMF-3 events within an RSC.

Functions as an engaged team member committed to supporting the Quality team’s objectives.

Trains QC inspectors on inspection techniques, procedures, and processes.

Serves as the primary Quality contact for production personnel and other relevant business functions.

Minimum Requirements

High School diploma or equivalent

1+ years’ experience in a regulated work environment

Knowledge of FDA Quality System Regulations and ISO13485 pertaining to medical device   manufacturing

Self-motivated with the ability to work independently

Strong attention to detail

Proficient in using computer-based systems daily

Effective team collaborator with a high level of individual engagement

Strong interpersonal and communication skills, both verbal and written

Organizational Relationship/Scope:

Reports to the Senior Manager, Quality or Quality Control Supervisor. The Quality Inspector II is accountable for delivery of prompt investigative work and detailed reporting. Working across multiple functions, The Quality Inspector II collaborates primarily with manufacturing, engineering and quality to assess nonconforming products and support supplier quality issues.

Working Conditions:

Manufacturing facility of medical devices and accessories. Controlled environmental working conditions.

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