Senior Quality Engineer

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

Location: Branchburg, NJ 08876 - this is 100% onsite

Schedule: Monday-Friday, 8:00am - 5:00pm with rotating evening and weekend on-call coverage

This is a fulltime, 12+ month, long-term contract position with full benefits!

I am hiring for 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 will have:

• 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

About us...Sterling Engineering, in business for 57 years ...we offer FULL BENEFITS! As a Sterling Engineering W2 employee on contract, you receive a Full Employee Benefits Package that includes Paid Time Off, Paid Holidays, 3 Medical plans to choose from, Dental & Vision plans, 401(k) with a match, and an Employee Stock Ownership (ESOP) plan.

Qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or genetic information.