Job Description

We are seeking a results-driven Quality Engineer to lead and elevate our Internal Audit Program across multiple production sites. In this pivotal role, you will be responsible for training and qualifying internal auditors, driving continuous improvement, and ensuring compliance with regulatory standards. Your expertise will directly impact product quality, process efficiency, and customer satisfaction.

Pay: $85-$100k, depending on experience

Key Responsibilities:

• Lead and maintain the Internal Audit Program by selecting, training, and qualifying cross-functional team members as auditors.
• Conduct thorough root cause analyses for customer complaints and non-conformances, and define effective CAPAs to prevent recurrence.
• Manage and sustain the CAPA system to ensure timely and effective resolution of quality issues.
• Partner with cross-functional teams to support validation activities (IOQ, PQ, Cleaning Studies) as required.
• Identify and execute Continuous Improvement Projects to streamline quality and manufacturing processes.
• Develop, revise, and implement Standard Operating Procedures (SOPs) to align with evolving quality standards.
• Analyze quality data trends—including complaints, deviations, and non-conformances—to drive strategic decisions and improvements.
• Conduct risk assessments such as Process Failure Mode and Effects Analysis (PFMEA) to proactively mitigate issues.
• Ensure adherence to company safety policies and regulatory guidelines in all operational areas.

Qualifications:

• Bachelor’s degree in Engineering or a science-related field (equivalent experience may be considered).
• Minimum of 3 years of experience in a GMP-regulated environment with working knowledge of 21 CFR 210/211, CAPA, and validation protocols.
• Proven ability to lead quality initiatives and solve complex problems using data-driven decision-making.
• Strong written and verbal communication skills, with an emphasis on clarity and precision.
• Familiarity with measurement tools and quality software such as Microsoft Office Suite, ERP/MRP systems, and Minitab.
• Demonstrated experience in continuous improvement and process optimization.

This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!

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