Top 180 Quality assurance engineer Jobs in Fort Lee Nj

Quality Engineer
Interact Engineering LLC —Whippany, NJ
- $45 an hour
- Temporary
- 5 years
- Mid-level
- Master's degree
Quick Apply
Contract QA Engineer - AI Trainer
DataAnnotation —Newark, NJ
- $50 - $100 an hour
- Part-time
- Remote
- Writing skills
- English
- Mid-level
- Flexible schedule
Quick Apply
Validation Engineer
The Assurance Group —Pine Brook, NJ
- $75,000 - $85,000 a year
- Full-time
- Microsoft Excel
- Microsoft Outlook
- Engineering
- Health insurance
- Paid time off
Quick Apply
11d
Senior QA Engineer
Cross River —Fort Lee, NJ
- $120,000 - $160,000 a year
- Hybrid work
- 3 years
- Mentoring
- Senior level
Quick Apply
QA Engineer II
Cross River —Fort Lee, NJ
- $110,000 - $140,000 a year
- Hybrid work
- Mid-level
- SQL
- Analysis skills
Quick Apply
Customer Quality Engineer
Airtech Group Inc —Rutherford, NJ
- $109,800 - $164,600 a year
- Online Application
- 5 years
- Engineering
- Mid-level
- Health insurance
- Paid time off
Manufacturing Quality Engineer
Airtech Group Inc —Rutherford, NJ
- $109,800 - $164,600 a year
- Online Application
- 5 years
- Engineering
- Mid-level
- Health insurance
- Paid time off
Quality Engineer
Kulite Semiconductor Products, Inc. —Leonia, NJ
- $60,000 - $75,000 a year
- Full-time
- Bachelor of Science
- Engineering
- Mid-level
- Health insurance
- Dental insurance
Quality Assurance (QA) Engineer
Array —New York, NY
- From $75,000 a year
- Full-time
- Remote
- Azure
- Mid-level
- Java
- Commuter assistance
- Health insurance
Quick Apply
Staff Quality Assurance Engineer
Pearson —Hoboken, NJ
- $130,000 - $150,000 a year
- Full-time
- Hybrid work
- Office
- Java
- 8 years
Sr Associate, Quality Engineer
L3Harris Technologies —Clifton, NJ
- $73,000 - $136,000 a year
- Weekends as needed
- Analysis skills
- Bachelor's degree
- Experience equivalent to degree accepted
- Paid holidays
- Disability insurance
Junior Quality Engineer, Design Assurance
Orthofix —Verona, NJ
- $35 an hour
- Full-time
- English
- Office
- Travel
- Health insurance
Test Engineer
New York Power Authority —White Plains, NY
- $118,000 - $162,800 a year
- Computer science
- Computer Science
- 5 years
API Test Engineer (Backend) - Jersey City, US
Photon —Jersey City, NJ
- $42,000 - $147,000 a year
- Java
- Senior level
- Paid holidays
- Health insurance
Quality Engineer
Flex Tek —Elmwood Park, NJ
- Full-time
- Engineering
- Mid-level
- Microsoft Office
Quick Apply
12d
Quality Chemical Engineer
KLA —Totowa, NJ
- $75,000 - $127,500 a year
- Full-time
- Laboratory experience
- Master's degree
- Bachelor's degree
- Employee stock purchase plan
- Paid holidays
3d
Quality Assurance Engineer
Tradeweb Markets —Jersey City, NJ
- $135,000 - $180,000 a year
- Full-time
- 5 years
- Writing skills
- Analysis skills
- Travel reimbursement
- Commuter assistance
Quality Engineering, Specialist
L3Harris Technologies —Clifton, NJ
- $8,400 - $156,000 a year
- Mid-level
- Bachelor's degree
- 2 years
- Paid holidays
- Disability insurance
Software QA Engineer
Elevate HR —New York, NY
- $88,000 - $125,000 a year
- Full-time
- Computer Science
- Mid-level
- Residential
Lead - API Test Engineer (Front end) - Jersey City, US
Photon —Jersey City, NJ
- $48,000 - $168,000 a year
- Senior level
- Python
- Paid holidays
- Health insurance

I want to receive the latest job alert for quality assurance engineer in fort lee nj

By signing in to your account, you agree to SimplyHired's Terms of Service and consent to our Cookie and Privacy Policy.

Explore jobs in more locations

quality assurance engineer jobs near fort lee nj

Quality Engineer

Interact Engineering LLC
Whippany, NJ

Quick Apply

Job Details

Temporary | Full-time
$45 an hour

Qualifications

Chemical Engineering
Drug regulation
Master's degree
Manufacturing facility experience
Bachelor's degree
Medical device manufacturing facility experience
Pharmaceutical company experience
Cleanroom experience
Biomedical regulatory compliance
Root cause analysis
ISO 13485
FDA regulations
Pharmaceutical manufacturing facility experience

Full Job Description

OVERVIEW

The Quality Engineer will support the aseptic manufacturing and quality systems for sterile drug products packaged in glass vials and prefilled syringes. This role ensures compliance with applicable regulatory requirements including US FDA 21 CFR Parts 210, 211, 820, EU GMP Annex 1, and ISO 13485.

The position is responsible for the Quality support functions associated with the manufacturing and packaging of aseptic fill products like Syringes, vials and Cartridges. The position is responsible for the timely assessment of Quality documents associated with the production and packaging of aseptic fill products. This position will also manage projects associated with process, documentation and other improvements necessary in the Quality arena.

This role is 100% on site in Whippany, NJ.

ESSENTIAL FUNCTIONS

Key Responsibilities:

1. Quality Systems & Compliance

o Ensure compliance with cGMP, Quality System Regulations (QSR), and ISO 13485 requirements in aseptic manufacturing and packaging.

o Support the implementation and continuous improvement of quality systems: CAPA, deviations, change control, risk management, and supplier qualification.

o Author, review, and approve SOPs, protocols, batch records, and validation documents.

o Maintain compliance with FDA 21 CFR Part 210/211 (drug manufacturing), Part 820 (device QSR), and EU Annex 1 sterile manufacturing requirements.

2. Aseptic Manufacturing Oversight

o Provide on-floor quality support for aseptic filling operations of glass vials and prefilled syringes.

o Perform aseptic technique observation, media fill support, and personnel qualification oversight.

o Review and assess cleanroom classification, environmental monitoring, and process simulations.

o Verify compliance of gowning, cleaning, and disinfection practices per EU Annex 1 and FDA expectations.

3. Process & Equipment Support

o Support validation and qualification of aseptic filling lines, isolators, RABS, cleanrooms, utilities, and associated equipment.

o Participate in FAT, SAT, IQ/OQ/PQ and technical transfers for sterile manufacturing lines.

o Ensure equipment, packaging, and container-closure systems for glass vials and prefilled syringes meet USP <1207> container closure integrity testing (CCIT) requirements.

o Conduct risk assessments (FMEA, HACCP, risk-based approach per ICH Q9/Q10).

4. Investigations & Continuous Improvement

o Lead and support root cause investigations for deviations, OOS/OOT, and complaints related to aseptic operations and packaging.

o Develop and track CAPAs to ensure timely and effective implementation.

o Monitor process performance and quality trends to identify opportunities for improvement.

o Drive implementation of quality by design (QbD) and continuous improvement initiatives in aseptic processes.

5. Documentation & Regulatory Support

o Ensure accurate, complete, and contemporaneous documentation in compliance with data integrity principles (ALCOA+).

o Support preparation for regulatory inspections (FDA, EMA, Notified Body, MHRA, etc.).

o Assist in responding to inspection findings and regulatory queries.

o Prepare quality reports, metrics, and risk assessments for management review.

6. Continuous Improvement:

o Drive continuous improvement initiatives through lean manufacturing principles and Six Sigma methodologies.

o Lead quality improvement projects, collaborating with teams to enhance product quality, reduce waste, and improve operational efficiency.

POSITION QUALIFICATIONS

EDUCATION/EXPERIENCE:

· Bachelor’s or master’s degree in pharmacy, Microbiology, Biotechnology, Chemical Engineering, or related Life Sciences/Engineering field.

· 5+ years of experience in aseptic pharmaceutical or medical device manufacturing, with direct involvement in glass vial and/or prefilled syringe filling operations.

· Strong understanding of cGMP, FDA 21 CFR Parts 210/211/820, EU Annex 1, ISO 13485.

· Experience with validation, aseptic process simulations, cleanroom classification, and CCIT.

· Prior exposure to combination product regulations is highly desirable.

Skills & Competencies:

o Strong knowledge of aseptic techniques, sterile barrier systems, and contamination control strategies.

o Familiarity with quality risk management, statistical data analysis, and process capability tools.

o Excellent technical writing and communication skills.

o Strong problem-solving and root cause analysis skills.

o Ability to work in a dynamic, fast paced, and highly regulated environment.

Physical Requirements:

o Primarily site-based with routine presence in classified cleanroom environments.

o Ability to stand for up to 8 hours per day.

Frequent sitting, standing, walking, reading written documents and use of computer monitor screen, talking, writing, listening

o May require gowning certification for Grade A/B aseptic areas.

o Occasional travel for supplier audits, training, or regulatory inspections.

Pay: $45.00 per hour

Work Location: In person

Quick Apply

Refine Your Search

quality assurance engineer jobs in fort lee nj

Quality Engineer

Contract QA Engineer - AI Trainer

Validation Engineer

Senior QA Engineer

QA Engineer II

Customer Quality Engineer

Manufacturing Quality Engineer

Quality Engineer

Quality Assurance (QA) Engineer

Staff Quality Assurance Engineer

Sr Associate, Quality Engineer

Junior Quality Engineer, Design Assurance

Test Engineer

API Test Engineer (Backend) - Jersey City, US

Quality Engineer

Quality Chemical Engineer

Quality Assurance Engineer

Quality Engineering, Specialist

Software QA Engineer

Lead - API Test Engineer (Front end) - Jersey City, US

I want to receive the latest job alert for quality assurance engineer in fort lee nj

Related Searches

Explore jobs in more locations

Job Seeker Tools

Employer Tools

Browse

Stay Connected