Quality Inspector II - AID

Job Summary

Join Werfen's Autoimmunity business as a Quality Inspector II where your work directly impacts the delivery of life-changing diagnostic products used by hospitals and laboratories worldwide. As a Quality Inspector II, you will play a critical role in inspecting and releasing incoming raw materials, components, chemicals, labels, and packaging materials, ensuring they meet FDA, ISO 13485, and company quality standards before entering production.

After receiving thorough training, you will work independently to perform detailed inspections, SAP transactions, documentation review, NCR generation, and material movement throughout the warehouse environment while partnering with teams across manufacturing, product release, planning, and leadership. This is an excellent opportunity for a self-motivated quality professional who enjoys hands-on work, thrives in a regulated environment, and wants to contribute to a mission focused on helping patients receive faster, more accurate diagnoses and better health outcomes.

Key Accountabilities

• Inspection:
  Conduct visual, dimensional, and functional inspection, as directed by procedures and specifications on incoming materials, components, assemblies, and products.
• Transactions:
  Perform inventory computer transactions for inspection completion, transfers, and releases.
• Ensure measurement, test and inspection equipment is calibrated and in good condition.
• Identification and Status:
  Ensure that materials maintain proper identification, traceability, and inspection/test status. Transfer quarantine and released materials to correct storage area for status and storage requirements.
• Nonconformances:
  Generate nonconformance reports. Execute disposition of nonconforming product. Pulling quarantine components for departments as needed.
• Environmental Monitoring:
  Sampling air, surface, and deionized water system and monitoring systems. Processing water samples for the Cleaning Validation Program.
• Completes, organizes, reviews, maintains, and archives quality control records.
• Interacts with ISO notified bodies auditors to explain actions of Quality Inspection.
• Coordinates disposal of waste, expired materials, and hazardous materials.
• Other duties as assigned.

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

Networking/Key Relationships

• Planning
• Receiving
• Quality Assurance
• EHS
• Product Testing
• Manufacturing
• Research & Development, including Manufacturing Technical Service (MTS)
• Purchasing
• Product Complaint Group
• Global Support Service (GSS)

Minimum Knowledge & Experience required for the position:

• High School Diploma or general education degree (GED).
• Five (5) years' work experience required of which two (2) should be inspection.
• Experience working in ISO 13485 or FDA regulated environment, required.
• Basic experience with Enterprise Resource Planning (ERP) systems preferred. SAP strongly preferred.

Skills & Capabilities:

• Advanced ability to successfully manage multiple tasks in a fast-paced environment in a team and/or individual capacity.
• Working ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists required.
• Working SAP transaction experience.
• Working knowledge in the use of gauges and other measuring devices preferred.
• Working knowledge of quality and quality control principles for in vitro diagnostics manufacturing.
• Working knowledge of the interconnections between the nonconformance process and use of nonconforming item preferred.
• Working knowledge of units of measure and basic mathematic skills.
• Basic with working knowledge in Microsoft Office Suite:
  Word, Excel, Access, Outlook, Power Point…