Quality Inspector II

Werfenlife SA.; San Diego (CA); On-site; USD 100,000 - 125,000; Full time

Job summary

An established industry player is seeking a Quality Inspector II to ensure product quality and compliance. This position involves conducting inspections, managing nonconformances, and maintaining quality control records. The ideal candidate will thrive in a fast-paced environment, possess a keen eye for detail, and have a solid background in quality control principles. Join a company dedicated to innovation and quality in the healthcare sector, where your contributions will enhance patient care and improve hospital efficiency. This is a fantastic opportunity for those looking to grow in a supportive and dynamic workplace.

Qualifications

• 5 years experience, 2 in inspection, in ISO 13485 or FDA environments.
• Basic ERP experience preferred, especially with SAP.

Responsibilities

• Conduct inspections on incoming materials and products.
• Generate nonconformance reports and manage quarantine materials.

Skills

Attention to Detail

Problem Solving

Quality Control Principles

Multi-tasking

Education

High School Diploma or GED

Tools

SAP

Microsoft Office Suite

Job description

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

The Quality Inspector II 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.

Responsibilities

Key Accountabilities

1. Inspection: Conduct visual, dimensional, and functional inspection, as directed by procedures and specifications on incoming materials, components, assemblies, and products.
2. Transactions: Perform inventory computer transactions for inspection completion, transfers, and releases.
3. Ensure measurement, test and inspection equipment is calibrated and in good condition.
4. 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.
5. Nonconformances: Generate nonconformance reports. Execute disposition of nonconforming product. Pulling quarantine components for departments as needed.
6. Environmental Monitoring: Sampling air, surface, and deionized water system and monitoring systems. Processing water samples for the Cleaning Validation Program.
7. Completes, organizes, reviews, maintains, and archives quality control records.
8. Interacts with ISO notified bodies auditors to explain actions of Quality Inspection.
9. Coordinates disposal of waste, expired materials, and hazardous materials.
10. Other duties as assigned.

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

Qualifications

Minimum Knowledge & Experience required for the position:

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

Skills & Capabilities:

1. Advanced ability to successfully manage multiple tasks in a fast-paced environment in a team and/or individual capacity.
2. Working ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists required.
3. Working knowledge in the use of gauges and other measuring devices preferred.
4. Working knowledge of quality and quality control principles for in vitro diagnostics manufacturing.
5. Working knowledge of the interconnections between the nonconformance process and use of nonconforming item preferred.
6. Working knowledge of units of measure and basic mathematic skills.
7. Basic with working knowledge in Microsoft Office Suite: Word, Excel, Access, Outlook, Power Point preferred.
8. 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.

Other Duties and Acknowledgement:

The above statements are intended to describe the general nature and level of work being performed by the incumbent. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of this position. Note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. This job description does not constitute or contain a contract or employment promise of any kind. Nothing contained herein modifies the at-will nature of employment with Werfen.

The salary range for this position is currently $24-$29/hr. Individual compensation is based on the candidate’s qualifications for the position, including experience, skills, knowledge, education, certifications, internal equity, budget and/or other business and organizational needs.

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.