Onsite Senior Quality Engineer — 12-Month Contract,Benefits

Sterling Engineering; Somerville (NJ); On-site; USD 105,000 - 145,000; Full time

Benefits offered by this job

Full benefits

Multiple medical plans

Dental & Vision

401(k) with match

ESOP

Job summary

Sterling Engineering, Branchburg, NJ, is seeking a Senior Quality Engineer to support manufacturing operations, equipment and automation projects, validation, deviations, CAPA, risk management, and Quality System compliance within a regulated production facility.

The ideal candidate has 6+ years in Manufacturing Quality or Quality Engineering in the U.S., knowledge of ISO 13485, ISO 14971, and FDA 21 CFR Part 820/QMSR, strong deviation, CAPA, root-cause and FMEA experience, and

Qualifications

• 6+ years of Manufacturing Quality or Quality Engineering experience in the U.S.
• ISO 13485, ISO 14971, and FDA 21 CFR Part 820/QMSR knowledge
• Strong deviation, CAPA, root-cause analysis, and FMEA experience
• Qualification/validation and manufacturing-process knowledge
• Pharmaceutical, biotechnology, or medical-device experience

Responsibilities

• Support manufacturing operations, equipment and automation projects, validation, deviations, CAPA, risk management, and Quality System compliance within a regulated production facility.

Skills

Quality Engineering

Job description

Sterling Engineering, Branchburg, NJ, is seeking a Senior Quality Engineer to support manufacturing operations, equipment and automation projects, validation, deviations, CAPA, risk management, and Quality System compliance within a regulated production facility.

The ideal candidate has 6+ years in Manufacturing Quality or Quality Engineering in the U.S., knowledge of ISO 13485, ISO 14971, and FDA 21 CFR Part 820/QMSR, strong deviation, CAPA, root-cause and FMEA experience, and