Job Description

Quality Engineer – Medical/Pharmaceutical Packaging Manufacturing

📍 Location: Greenville, SC | Full-Time | On-Site

We are currently seeking a skilled Quality Engineer to join our Quality Department within an FDA-regulated manufacturing environment. This individual will play a critical role in supporting validation efforts, managing quality systems, and ensuring ongoing compliance with internal, customer, and regulatory requirements.

This position is ideal for a detail-oriented professional with strong problem-solving skills and hands-on experience in quality assurance within the medical device or pharmaceutical industry.

Key Responsibilities:

• Lead and execute validation activities, including IQ/OQ/PQ protocols for equipment and process qualification.
• Develop, implement, and maintain the Master Validation Plan and associated documentation.
• Support the Cleaning Validation Program, Change Control Process, and CAPA Tracking Program.
• Create, revise, and route Master Manufacturing Batch Records, including review of completed records.
• Participate in investigations of quality events and customer complaints; assist in implementing corrective and preventive actions.
• Contribute to internal and customer audits and regulatory inspections.
• Prepare technical documentation, data analysis reports, and formal presentations for management and external stakeholders.
• Represent the company professionally during customer and vendor site visits.

Qualifications:

• Bachelor’s Degree in Engineering, Science, Chemistry, or a related field.
• Minimum of 2 years of experience in a Quality role within an FDA-regulated manufacturing environment.
• Working knowledge of GMP, ISO 13485, and applicable regulatory requirements.
• Experience with validation of manufacturing and packaging equipment (SATs, IQ/OQ/PQ).
• Proficiency in Microsoft Office; Minitab experience preferred.
• Excellent written and verbal communication skills.
• Strong organizational skills, attention to detail, and ability to work independently.

Preferred Certifications:

• Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), Six Sigma, or Lean Manufacturing certifications are preferred but not required.

If you are a self-motivated professional who thrives in a compliance-focused, collaborative environment, we encourage you to apply. This is an excellent opportunity to join a dedicated team committed to product quality, continuous improvement, and regulatory excellence.

Job Tags

Similar Jobs