Quality Assurance Specialist

Linde • Los Angeles, CA

2d • Onsite

About The Position

The Quality Assurance Specialist will review all steps performed to ensure manufacturing processes comply with the Batch Production Record Report findings of in-process errors and provide follow-up to guarantee corrective actions are adequately completed. This role will perform and coordinate quality investigations, implementing corrective and preventive actions and ensuring timely closure. The specialist will support product quality complaint investigations, assist in data processing of adverse events, appropriate reporting for U.S. and Canada complaints, and participate in resolving non-conformances. Additionally, they will conduct quality reviews of System Preventative Maintenance activities and support continuous quality improvement initiatives. The role involves providing training on Good Manufacturing Practices and quality principles across departments, maintaining training schedules and records, and assisting with tracking and trending deviations and complaints to support quality monitoring efforts. The specialist will also ensure product disposition approvals, including release, distribution, or rejection, and verify labels meet all internal and external requirements.

Requirements

• Bachelor’s or Associate’s degree in Science, Engineering, or a related technical field
• Knowledgeable in FDA regulations for medical products, specifically 21 CFR parts 210 and 211
• Strong communication skills
• Organizational agility
• Solid organizational skills with proficiency in Microsoft Office applications and Lotus Notes database

Nice To Haves

• Background in quality assurance for medical products is preferred
• Basic understanding of HTML and JavaScript is preferred
• Experience with ISO 9001, ISO 13485, or other regulatory standards is advantageous

Responsibilities

• Review all steps performed to ensure manufacturing processes comply with the Batch Production Record Report findings of in-process errors and provide follow-up to guarantee corrective actions are adequately completed
• Perform and coordinate quality investigations, implementing corrective and preventive actions and ensuring timely closure
• Support product quality complaint investigations, assist in data processing of adverse events, appropriate reporting for U.S. and Canada complaints, and participate in resolving non-conformances
• Conduct quality reviews of System Preventative Maintenance activities and support continuous quality improvement initiatives
• Provide training on Good Manufacturing Practices and quality principles across departments, maintaining training schedules and records
• Assist with tracking and trending deviations and complaints to support quality monitoring efforts
• Ensure product disposition approvals, including release, distribution, or rejection, and verify labels meet all internal and external requirements

Benefits

• Competitive compensation
• Outstanding benefits package
• Access to health, dental, disability, and life insurance
• Paid holidays and vacation
• Employee discount program
• Opportunities for educational and professional growth

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree