Quality Engineer – Medical /Pharma Packaging Manufacturing
Location: Greenville, SC| On-site
Are you passionate about quality, validation, and continuous improvement in highly regulated environments? Join a team that values your technical expertise and attention to detail!
We’re seeking a Quality Engineer to support validation programs, change control processes, and quality event tracking within a well-established, FDA-regulated manufacturing facility. This is a hands-on role ideal for a problem solver with a strong understanding of Good Manufacturing Practices and a proactive mindset.
What You’ll Do:
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Lead and perform validation activities including IQ, OQ, and PQ on new and existing equipment.
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Develop and manage validation protocols, test plans, and reports.
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Review, update, and control Master Manufacturing Batch Records and ensure compliance to regulatory standards.
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Support CAPA and change control programs, analyzing root causes and tracking resolutions.
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Participate in internal and external audits and ensure alignment with FDA, ISO 13485, and customer specifications.
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Assist in the investigation of quality complaints and out-of-specification events.
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Present findings and updates in meetings with customers, vendors, and internal stakeholders.
What You Bring:
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Bachelor’s Degree in Engineering or a related science field (Chemistry, Microbiology).
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2+ years of experience in an FDA-regulated environment.
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Knowledge of validation principles and GMPs (IQ/OQ/PQ, SATs, Cleaning Validation, etc.).
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Familiarity with ISO 13485, FDA, and EPA regulatory requirements.
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Proficiency in Microsoft Office; Minitab a plus.
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Detail-oriented, organized, and skilled in problem-solving.
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Excellent communication and interpersonal skills.
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Self-motivated with the ability to work independently and collaboratively.
Preferred Certifications:
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CQE, CQA, Six Sigma, or Lean Certifications highly desirable.
Why Join Us?
You’ll work in a collaborative, quality-driven environment with a company that values your initiative and rewards your contributions. If you’re ready to bring your validation expertise and passion for compliance to a team that’s focused on excellence, we want to meet you.
Apply today and be part of something meaningful!
