Quality Engineer

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)

Compensation & Benefits:

• $85-100k
• Medical, Dental, Vision