Quality Engineer

Contract-to-Hire Opportunity | Advantage Technical

Schedule: 1st Shift, Monday–Friday

Pay Rate: Up to approximately $44-49/hour

Advantage Technical is partnering with a regulated manufacturing organization to identify an experienced Senior Quality Engineer for a contract-to-hire opportunity.

This role will support site Quality Assurance programs, regulatory compliance, customer quality activities, process improvement, validation, investigations, and continuous improvement initiatives. The Senior Quality Engineer will work cross-functionally with Manufacturing, Engineering, Operations, Regulatory, Suppliers, and customers to improve product quality, strengthen quality systems, and support compliant manufacturing operations.

The ideal candidate will bring strong experience working in pharmaceutical, biotechnology, chemical, or similarly regulated manufacturing environments and will be comfortable working within cGMP and ISO-based quality systems.

• Support implementation and continuous improvement of site Quality Assurance programs and processes.
• Ensure compliance with applicable quality standards, internal procedures, cGMP requirements, ISO standards, FDA expectations, and other applicable regulatory requirements.
• Develop, implement, and improve inspection methods, testing processes, validation activities, and quality-control procedures.
• Lead and support CAPA investigations
  , root cause analysis, corrective actions, and preventive improvement initiatives.
• Investigate manufacturing and product-quality issues and develop sustainable solutions to prevent recurrence.
• Support complaint investigations and customer responses
  , ensuring issues are investigated thoroughly and resolved in a timely manner.
• Serve as a key Quality contact for customers, suppliers, vendors, and regulatory or certification organizations.
• Lead or support customer audits, certification audits, surveillance audits, and internal audits.
• Support supplier-quality activities, including supplier audits, issue resolution, and performance improvement.
• Coordinate and support process-validation and quality-validation initiatives.
• Apply statistical methods and SPC techniques to evaluate process performance, identify trends, and support data-driven quality decisions.
• Analyze product, process, and testing data to identify quality trends and opportunities for improvement.
• Support development, revision, and implementation of SOPs, quality procedures, and controlled documentation.
• Identify opportunities to improve defect detection, process capability, testing effectiveness, and corrective-action workflows.
• Support stability, validation, quality-system, and compliance activities as required.
• Work with cross-functional teams to balance product quality, manufacturing efficiency, regulatory requirements, and customer expectations.
• Provide Quality Engineering leadership and technical guidance on complex manufacturing and compliance issues.
• Drive continuous improvement initiatives focused on quality, compliance, process consistency, and operational effectiveness.

The Senior Quality Engineer will provide direct support to quality systems and activities that may include:

• CAPA
• cGMP compliance
• ISO Quality Systems
• Stability Programs
• Statistical Process Control
• Process Validation
• Internal & External Audits
• Corrective and Preventive Action
• Quality Documentation

• Minimum of 5 years of Quality Engineering or related Quality Assurance experience
  .
• Experience working in pharmaceutical, biotechnology, chemical, or similarly regulated manufacturing environments
  .
• Strong experience working within cGMP and ISO-regulated quality systems
  .
• Experience supporting CAPA, investigations, audits, complaint…