Top 2291 Quality systems engineer capa Jobs

Quality Engineer
Katalyst Healthcares & Life Sciences —Boston, MA
- Contract
- Hybrid work
- Engineering
- Mid-level
- 3 years
Quick Apply
14d
Quality Systems Engineer
VulcanForms Inc. —Devens, MA
- $75,413 - $103,692 a year
- Full-time
- Writing skills
- Mid-level
- 3 years
- Health insurance
- Dental insurance
Quick Apply
Quality Engineer - CAPA
Siemens Healthineers —Hoffman Estates, IL
- $98,140 - $134,937 a year
- Full-time
- Engineering
- Mid-level
- Analysis skills
- Disability insurance
- Health insurance
Quality Engineer
Izzio Artisan Bakery LLC —Thornton, CO
- $75,000 - $85,000 a year
- Weekends as needed
- Mid-level
- Analysis skills
- Bachelor's degree
- Paid holidays
- Health insurance
Quick Apply
Quality Engineer
Bonutti Research, Inc. —Effingham, IL
- $60,000 - $65,000 a year
- Full-time
- Background check
- Bachelor of Science
- Mid-level
- Dental insurance
- 401(k)
Quick Apply
9d
Quality Manager CNC Inspection & Customer Quality
DW PRODUCTS —Cedar Rapids, IA
- Full-time
- Mid-level
- US work authorization
- In-person
- Paid holidays
- Disability insurance
Quick Apply
Senior Quality Engineer
Calnetix Technologies, LLC —Cypress, CA
- From $130,000 a year
- Full-time
- Engineering
- 8 years
- Analysis skills
Quick Apply
Quality Engineer
Elgin Die Mold —Pingree Grove, IL
- $80,000 - $110,000 a year
- Full-time
- In-person
- Senior level
- Health insurance
- Dental insurance
Quick Apply
Regional Quality Engineer
Rohrer Corporation —Huntley, IL
- $105,000 - $130,000 a year
- 5 years
- Engineering
- Analysis skills
Quick Apply
Quality Assurance Engineer
Voltage LLC —Timberlake, NC
- Full-time
- Ability to walk for extended periods
- Engineering
- Mid-level
- Health savings account
- Relocation assistance
Quick Apply
Quality & Manufacturing Engineer - Sewn Products
Manufacturing Company in Concord NC —Concord, NC
- Full-time
- Engineering
- Mid-level
- Analysis skills
- Health insurance
- Dental insurance
Quick Apply
9d
Quality Assurance Manager
Minerals Technologies —Adams, MA
- Full-time
- Management
- 5 years
- English
- Disability insurance
- Health insurance
Quality Manager
Piezo Technologies —Indianapolis, IN
- From $110,000 a year
- Full-time
- 5 years
- Engineering
- Office
- Health insurance
- Dental insurance
Quick Apply
14d
Sr. Facilities Engineer
Ultragenyx Pharmaceutical —Bedford, MA
- $157,800 - $194,900 a year
- Full-time
- Bachelor of Science
- System design
- Ability to climb stairs
- Gym membership
Manufacturing Quality Engineer
Drummond Scientific Company —Broomall, PA
- $90,000 a year
- Full-time
- Background check
- Engineering
- Mid-level
- Health insurance
- Dental insurance
Quick Apply
Quality Engineer
Hi-Lex Controls —Litchfield, MI
- Full-time
- Mid-level
- Office
Quick Apply
Senior Quality Systems Engineer
Avanos Medical —Alpharetta, GA
- Full-time
- Management
- Engineering
- Master's degree
- Health insurance
- 401(k) matching
Quality Control Assistant
Core Plastech International Inc —Waterloo, IA
- From $20 an hour
- Full-time
- Computer literacy
- High school diploma or GED
- Analysis skills
- Health insurance
- Dental insurance
Quick Apply
12d
Director of Quality and Regulartory Affairs
VIVA MFG, LLC. —Tampa, FL
- $150,000 - $180,000 a year
- Full-time
- 7 years
- Laboratory experience
- Master's degree
- Health insurance
- Dental insurance
Quick Apply
2d
Manufacturing Engineer
Piezo Technologies —Indianapolis, IN
- From $80,000 a year
- Full-time
- 5 years
- Bachelor of Science
- English
- Health insurance
- Dental insurance
Quick Apply

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Quality Engineer

Katalyst Healthcares & Life Sciences -
Boston, MA

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Job Details

Contract
14 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
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

Refine Your Search

quality systems engineer capa jobs

Quality Engineer

Quality Systems Engineer

Quality Engineer - CAPA

Quality Engineer

Quality Engineer

Quality Manager CNC Inspection & Customer Quality

Senior Quality Engineer

Quality Engineer

Regional Quality Engineer

Quality Assurance Engineer

Quality & Manufacturing Engineer - Sewn Products

Quality Assurance Manager

Quality Manager

Sr. Facilities Engineer

Manufacturing Quality Engineer

Quality Engineer

Senior Quality Systems Engineer

Quality Control Assistant

Director of Quality and Regulartory Affairs

Manufacturing Engineer

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