Quality Engineer

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) #J-18808-Ljbffr