Top 10746 Quality engineer iso Jobs

Quality Engineer
Katalyst Healthcares & Life Sciences —Boston, MA
- Contract
- Hybrid work
- Engineering
- Mid-level
- 3 years
Quick Apply
10d
Quality Engineer
U.S. Dynamics Corporation —Amityville, NY
- $80,000 - $95,000 a year
- Full-time
- Bachelor of Science
- Mid-level
- Analysis skills
- Opportunities for advancement
Quick Apply
Quality Engineer
Quanta Manufacturing Nashville —Fremont, CA
- $75,000 - $90,000 a year
- Full-time
- Bachelor of Science
- Mid-level
- Office
Quick Apply
Engineer I, Software Quality
FUJIFILM —Remote
- Remote
- Microsoft Excel
- Bachelor of Science
- Office
Quality Engineer
LG Energy Solution Michigan, Inc. —Phoenix, AZ
- Full-time
- Engineering
- Research
- Mid-level
- Paid holidays
- Disability insurance
Quick Apply
Quality Engineer I
Holtec —Camden, NJ
- $70,000 - $85,000 a year
- Mid-level
- High school diploma or GED
- Analysis skills
- Wellness program
- Commuter assistance
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Quality Engineer
Intercomp —Hamel, MN
- $80,000 - $120,000 a year
- Online Application
- ERP systems
- Analysis skills
- In-person
- Health insurance
- Dental insurance
Quick Apply
10d
Quality Engineer
Miller Industries, Inc. —Hermitage, PA
- Full-time
- Background check
- Microsoft Excel
- ERP systems
- AD&D insurance
- Paid holidays
Senior Controls Engineer – Power & Energy Systems
Interstates —Omaha, NE
- Bachelor of Science
- Office
- Continuous improvement
- Paid holidays
- Disability insurance
Quick Apply
CWI/ Welding Engineer
Columbus Hydraulics-- A Wipro Hydraulics Company —Columbus, NE
- Full-time
- Mid-level
- High school diploma or GED
- Ability to lift 50 pounds
- Health savings account
- Health insurance
Quick Apply
Health, Safety, & Environmental Engineer
Kao Corporation —Cincinnati, OH
- $80,000 - $105,000 a year
- Office
- 3 years
- Continuous improvement
- Health insurance
- 401(k) matching
Senior Quality Engineer
Calnetix Technologies, LLC —Cypress, CA
- From $130,000 a year
- Full-time
- Engineering
- 8 years
- Analysis skills
Quick Apply
Lead Electrical Engineer
Coherent Corp. —Fremont, CA
- $100,625 - $172,250 a year
- Overtime
- Mid-level
- Office
- Doctor of Philosophy
Quality Engineer
Delta Power Company —Rockford, IL
- $65,000 - $69,000 a year
- Full-time
- Microsoft Word
- Background check
- Microsoft Excel
- Health savings account
- Health insurance
Quick Apply
Senior Embedded Software Engineer
NextGen RF Design —North Mankato, MN
- $100,000 - $135,000 a year
- Online Application
- 7 years
- Management
- Computer Science
- Health insurance
- 401(k)
Quick Apply
SENIOR PROCESS ENGINEER / SCIENTIFIC MOLDING ENGINEER
Moldworx LLC —Chandler, AZ
- $125,000 - $150,000 a year
- Full-time
- Engineering
- Analysis skills
- Mentoring
- Health savings account
- Paid holidays
Quick Apply
Senior Quality Engineer
Johnson Screens Inc —New Brighton, MN
- $92,000 - $98,000 a year
- Full-time
- Management
- 5 years
- Engineering
- Health savings account
- AD&D insurance
Quick Apply
12d
Quality Control Inspection Engineer
ECA Medical Instruments —Newbury Park, CA
- $75,000 - $113,000 a year
- Full-time
- Microsoft Outlook
- Customer service
- 5 years
- Health savings account
- Health insurance
Quick Apply
Senior Facility Engineer
Lifecore Biomedical Inc —Chaska, MN
- $110,000 - $128,000 a year
- Full-time
- Bachelor of Science
- Engineering
- Organizational skills
- Health savings account
- Paid holidays
Production Manager & RF Engineer
Confidential —Simi Valley, CA
- $90,000 - $120,000 a year
- Weekends as needed
- Laboratory experience
- Mid-level
- 3 years
- Health savings account
- Health insurance
Quick Apply

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Quality Engineer

Katalyst Healthcares & Life Sciences -
Boston, MA

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Job Details

Contract
10 days ago

Qualifications

Mechanical blueprint interpretation
Investigations regulatory compliance
Defect resolution root cause analysis
Preventive action implementation
Corrective and preventive actions (CAPA)
GMP
Parts drawings
Bachelor's degree in engineering
Medical device manufacturing facility experience
Quality standards in production
Biomedical regulatory compliance
Productivity software
Investigating compliance violations
Product quality failure
FDA regulations
Failure analysis
Database software proficiency

Full Job Description

Job Description:
We are seeking an Quality Complaint Investigation to support complaint investigations, quality system activities, and continuous improvement initiatives within a regulated medical device manufacturing environment. The role involves analyzing quality data, conducting root cause investigations, supporting CAPA activities, and ensuring compliance with FDA and GMP standards .
Responsibilities:

Review customer complaints and associated service data to determine risk levels and identify problem/cause codes.
Conduct complaint investigations and perform detailed root cause analysis.
Analyze data from quality systems including Complaints, Field Corrective Actions (FCA), FDA MDRs, and other quality inputs to identify trends and systemic issues.
Prepare investigation summaries, reports, and recommendations based on analysis.
Review existing investigation reports and identify GMP compliance gaps.
Support development and implementation of corrective and preventive actions (CAPA).
Drive continuous improvement initiatives and process control activities.
Conduct data analysis using statistical and quality tools.
Support maintenance activities for existing product lines and quality systems.
Collaborate cross-functionally to improve product quality and compliance standards.

Requirements:

Bachelor's Degree in Engineering (B.E./B.Tech or equivalent).
1 3 years of experience in the Medical Device industry.
Knowledge of FDA Quality System Regulations (21 CFR 820) and cGMP requirements.
Experience in complaint handling, investigations, and root cause analysis.
Familiarity with CAPA processes and quality systems.
Strong analytical and problem-solving skills.
Experience with statistical tools/software such as Minitab is a plus.
Ability to read and interpret technical drawings and engineering documentation.
Proficiency in MS Office tools (Excel, Word, PowerPoint) and databases.
Ability to manage multiple tasks and projects effectively.

Preferred Experience:

Experience with ANSI/ISO/ASQC standards.
Exposure to continuous improvement methodologies and process controls.
Knowledge of medical device regulatory environments and compliance practices .

Work Environment:

FDA-regulated manufacturing environment.
Temperature and humidity-controlled workspace.
May require use of static-protective equipment while in designated work areas.

Physical Requirements:

Ability to sit for extended periods.
Good hand-eye coordination and dexterity.
Ability to lift up to 40 lbs when required.

Quick Apply

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quality engineer iso jobs

Quality Engineer

Quality Engineer

Quality Engineer

Engineer I, Software Quality

Quality Engineer

Quality Engineer I

Quality Engineer

Quality Engineer

Senior Controls Engineer – Power & Energy Systems

CWI/ Welding Engineer

Health, Safety, & Environmental Engineer

Senior Quality Engineer

Lead Electrical Engineer

Quality Engineer

Senior Embedded Software Engineer

SENIOR PROCESS ENGINEER / SCIENTIFIC MOLDING ENGINEER

Senior Quality Engineer

Quality Control Inspection Engineer

Senior Facility Engineer

Production Manager & RF Engineer

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