Overview
Quality Engineer Jobs in Greenville-Spartanburg-Anderson, South Carolina Area at Find Great People | FGP
Title: Quality Engineer
Company: Find Great People | FGP
Location: Greenville-Spartanburg-Anderson, South Carolina Area
Summary:
We are seeking a Quality Engineer to support manufacturing operations in a regulated medical device/pharmaceutical environment. This role is responsible for process and equipment validation, quality documentation, change control, and investigation activities, ensuring compliance with FDA, GMP, and customer requirements.
This is a hands‑on, non‑supervisory role ideal for a detail‑oriented quality professional who thrives in structured environments, values documentation accuracy, and enjoys working cross‑functionally with manufacturing, engineering, and customers.
Key Responsibilities
- Lead and execute validation activities, including capability studies, data analysis, and revalidation assessments of manufacturing processes and equipment.
- Develop, execute, and maintain IQ/OQ/PQ protocols for new equipment, packaging processes, and new product introductions.
- Establish and support master validation plans and qualification strategies.
- Create, review, and maintain Manufacturing Batch Records, ensuring accuracy, completeness, and regulatory compliance.
- Manage change control for batch records, equipment, and processes.
- Review completed batch records and communicate deviations, errors, or concerns.
- Support and track Corrective and Preventive Actions (CAPA) to completion.
- Assist with investigations related to quality complaints and out‑of‑specification events.
- Prepare quality reports, summaries, and trend analyses using charts, graphs, and spreadsheets.
- Participate in internal, customer, and regulatory audits.
- Communicate effectively with internal teams, customers, and auditors.
- Represent the company professionally during customer and vendor visits.
- Perform additional quality‑related duties as needed.
Required Qualifications
- Bachelor’s degree in Engineering, Science, Chemistry, Microbiology, or a related field.
- 2+ years of Quality Engineering or Quality Assurance experience in an FDA‑regulated manufacturing environment (medical device, pharmaceutical, or similar).
- Hands‑on experience with process and equipment validation (IQ/OQ/PQ).
- Strong working knowledge of Good Manufacturing Practices (GMP).
- Experience working with regulated documentation and batch records.
- Excellent written and verbal communication skills.
- High attention to detail and strong organizational skills.
- Ability to work independently and manage multiple priorities.
Preferred Qualifications
- Experience validating packaging equipment.
- Knowledge of FDA regulations, ISO 13485, and customer requirements.
- Familiarity with statistical tools (e.g., Minitab).
- Certifications such as CQE, CQA, Six Sigma, or Lean.
- Prior audit participation (customer or regulatory).
