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.
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.