Quality Controller - Quality Assurance

Nobel Biocare; Madison (WI); On-site; USD 65,000 - 90,000; Full time

Job summary

Nobel Biocare in Madison, WI seeks a Quality Controller to support QA activities across the product lifecycle, ensuring regulatory and quality requirements are met. You will inspect materials, in-process and finished devices, document results, and assist investigations and continuous improvement projects.

Work with Manufacturing, Engineering, Operations, and R&D to promote product quality and process effectiveness, participate in audits, and maintain quality records as needed.

Qualifications

• Experience supporting QA activities across product lifecycle.
• Familiarity with GDP and regulatory requirements.

Responsibilities

• Inspect incoming materials, in-process products, and finished devices.
• Document results following GDP and SOPs.
• Assist with MRB activities and complaint investigations.
• Support validation/verification protocols and data collection.
• Collaborate with Manufacturing, Engineering, and R&D to drive quality improvements.
• Assist audits and quality records maintenance.

Skills

Quality Assurance

GxP Compliance

Documentation

Data Analysis

Job description

Position Summary: The Quality Controller is responsible for supporting quality assurance activities across the product lifecycle to ensure compliance with applicable regulatory, quality system, and product requirements. This role performs inspection activities for incoming materials, in-process products, and finished devices while also supporting complaint investigations, nonconforming material management, validation activities, continuous improvement initiatives, and cross-functional quality projects. The Quality Controller works closely with Manufacturing, Engineering, Operations, and R&D to promote product quality, compliance, and process effectiveness.

Essential Duties And Responsibilities

• Perform inspection and testing activities for incoming materials, in-process products, and finished devices to ensure compliance with established specifications and acceptance criteria.
• Document inspection and testing results in accordance with Good Documentation Practices (GDP).
• Identify, document, and assist with investigation of nonconforming materials, products, and processes.
• Support Material Review Board (MRB) activities including product evaluation and disposition activities.
• Participate in complaint handling activities including complaint evaluation, investigation support, MDR assessments, and closure activities.
• Support validation and verification activities including protocol execution, data collection, test documentation, and report generation.
• Collaborate with Manufacturing, Engineering, Supply Chain, and R&D to evaluate process changes, product improvements, and quality concerns.
• Assist with implementation of quality improvements and continuous improvement initiatives.
• Support internal and external audits, inspections, and quality system activities as needed.
• Participate in development, review, and maintenance of procedures, work instructions, forms, and quality records.
• Analyze quality data and communicate trends, observations, and potential risks.
• Serve as a flexible quality resource supporting multiple Quality Assurance functions based on business needs.
• Perform other duties as assigned.

Incidental Duties: The above statements describe the general nature and level of work being performed in this job. They are not intended to be an exhaustive list of all duties, and indeed additional responsibilities may be assigned, as required, by management.