Quality Engineer

Integrated Resources, Inc

Fair Lawn, NJ

JOB DETAILS
SALARY
SKILLS
Analysis Skills, Biology, Biotech and Pharmaceutical, Change Control, Chemistry, Communication Skills, Consensus Building Skills, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Current Good Manufacturing Practice (cGMP), Data Analysis, Detail Oriented, Documentation Review, Establish Priorities, FDA (Food and Drug Administration), GMP (Good Manufacturing Practices), ISO (International Organization for Standardization), ISO 9001, Maintain Compliance, Manufacturing Operations, Medical Equipment, Microsoft Office, Presentation/Verbal Skills, Problem Solving Skills, Project/Program Management, Quality Assurance, Quality Engineering, Quality Management, Quality Metrics, Regulations, Risk Management, Root Cause Analysis, SAP, Standard Operating Procedures (SOP), Statistics, Technical Writing, Writing Skills
LOCATION
Fair Lawn, NJ
POSTED
15 days ago
Job Title: Quality Engineer
Job Location:  Fair Lawn, NJ 07410
Job Duration:  12 months (Possible Extension)

Shift hours: 1st shift 8:00 am – 5:00 pm
Payrate: $ $25/hr. on W2
 
Job Description
This role supports quality assurance and compliance activities within a GMP-regulated pharmaceutical, biotech, or medical device environment. Responsibilities include supporting deviation investigations, CAPA activities, SOP/documentation review, batch record management, and ensuring compliance with FDA and ISO quality standards. The position works cross-functionally with QA, manufacturing, and operations teams to maintain audit readiness and support continuous quality improvement initiatives.

Requirements
  • Bachelor's Degree plus 1 years of quality assurance experience in GMP/ISO regulated environments, preferably in medical devices, pharmaceuticals or biotechnology
  • Preferred Fields of Study: Life Sciences, Engineering, Chemistry or related scientific/technical field
  • Awareness of quality systems, cGMP regulations, and standards including ISO 13485, ISO 9001
  • Experience in quality tools and methodologies including risk management, root cause analysis, CAPA, and change control
  • Experience supporting investigations, analyzing quality data, and implementing effective corrective actions
  • Excellent documentation and technical writing skills for developing SOPs, protocols and reports
  • Experience in quality management software (TrackWise, SAP QM, etc.) and Microsoft Office suite
  • Demonstrated ability to build consensus and collaborate across functions
  • Strong verbal and written communication skills
  • Ability to work independently while contributing effectively in team environments
  • Strong attention to detail with analytical and problem-solving capabilities
  • Experience with statistical analysis tools and quality metrics reporting
  • Project management skills and ability to prioritize effectively.

About the Company

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Integrated Resources, Inc