Werfen

Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.

Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We're passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

Job Summary

The Quality Inspector I performs and documents inspection and testing per sampling plans and specifications. This individual will also be responsible for identifying, containing, and documenting nonconforming product, and generating NCRs. They will ensure materials and products accepted for use are in accordance with established quality specifications.

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.
• 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).
• Three (3) years' work experience required of which 1 should be inspection.
• Experience working in ISO 13485 or FDA regulated environment, preferred.
• 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.
• Basic ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists required.
• Basic knowledge in the use of gauges and other measuring devices preferred.
• Basic knowledge of quality and quality control principles for in vitro diagnostics manufacturing.
• Basic 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.

Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement.

Travel Requirements:

• None

Work Environment (US only):

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to communicate. Must be able to detect, identify and inspect scientific data. The employee will be required to stand and/or walk up to 8 hours per day and/or sit for up to 8 hours per day. Must be able to use hands to feel objects, including keyboard, telephone and pipettes or other lab equipment. May need to reach with hands and arms, climb stairs, balance, stoop, kneel or crouch. Will be required to talk and hear and have specific vision abilities, including close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. May occasionally have to lift and/or move up to 25 pounds. The noise level in the work environment will vary but is usually moderate. This position is very active and requires varying levels of mobility.

If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV.

Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact NAtalentacquisition@werfen.com for assistance.

We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team.

www.werfen.com