Quality Inspector II — GMP/ISO Compliance

Werfen; San Diego (CA); Hybride; USD 29 000 - 48 000; Plein temps

Avantages offerts par ce poste

Medical, dental, vision insurance

401k with employer match

Paid vacation and sick leave

Performance-based bonus

Résumé du poste

Werfen is seeking a Quality Inspector II to join our Autoimmunity division in the United States. You will inspect incoming raw materials, components, and packaging to ensure they meet FDA, ISO 13485, and internal standards before entering production.

After training, you will perform SAP transactions, review documentation, generate NCRs, and move materials within the warehouse while collaborating with manufacturing, planning, and leadership.

Qualifications

• The candidate has a high school diploma or GED and at least five years of experience, including two in inspection.
• Must have experience in ISO 13485 or FDA regulated environments.
• Basic proficiency with ERP systems; SAP strongly preferred.

Responsabilités

• Perform visual, dimensional, and functional inspections of incoming materials and components.
• Complete inventory transactions for inspection, transfers, and releases in SAP.
• Ensure calibration and proper condition of measuring equipment.
• Maintain material traceability and inspection/test status throughout storage.
• Generate nonconformance reports and disposition nonconforming products.
• Support environmental monitoring and Cleaning Validation programs.
• Maintain quality control records and collaborate with auditors and cross-functional teams.
• Assist with waste and hazardous material disposal as required.

Connaissances

Attention to detail

Multitasking

Quality control

Problem solving

Formation

High School Diploma or GED

Outils

SAP

ERP systems

Description du poste

Country

United States

Shift

1st

About the Position

Introduction

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.

Overview

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.

Responsibilities

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)

Qualifications

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 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.
• 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.

Compensation

The annual base hourly range for this role is currently $27 to $35. Individual employee compensation will ultimately depend on factors including education, relevant experience, skillset, knowledge, and particular business needs.

This role is eligible for medical, dental, and vision insurance, 401k plan retirement benefits with an employer match, as well as paid vacation and sick leave.Our sales roles are eligible for participation in a commission plan and our management,and select professional roles,are eligible for a performance-based bonus.

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 [e-mail] 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.