Quality Inspector II - AID
Werfen
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.
Job description
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.
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 preferred.
- Good communication skills.
- Strong attention to detail including proofreading.
Requirements
- 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.
- 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 preferred.
- Good communication skills.
- Strong attention to detail including proofreading.
Benefits
- Medical, Dental & Vision
- 401(k) Matching
- Paid Vacation
- Sick Leave
- Performance-based Bonus
Company overview
Werfen is a global leader in specialized diagnostics, founded in 1966 in Barcelona, Spain as a family-owned innovative company. The organization has established itself as a worldwide authority in five key clinical areas: Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant diagnostics. With headquarters in Barcelona and technology centers strategically located in the United States and Europe, Werfen operates directly in 30 countries and serves more than 100 territories through distributors. The company achieved remarkable financial performance with worldwide sales exceeding €2.2 billion in 2024, supported by a workforce of over 7,000 employees globally. Werfen's comprehensive portfolio includes advanced diagnostic systems, reagents, laboratory automation solutions, and point-of-care testing platforms that enable healthcare providers to deliver precise and timely patient care. Their innovative technologies span from blood gas analyzers with hemolysis detection capabilities to automated immunoassay systems and specialized diagnostic assays. As a vertically integrated diagnostics company, Werfen maintains complete control over research, development, manufacturing, and distribution, ensuring quality and reliability across their product lines while continuously advancing diagnostic science to address critical healthcare challenges worldwide.