Top 32 quality engineer Jobs in boca raton fl

Quality Engineer
Clinical Diagnostic Solutions, Inc. —Plantation, FL
- $70,000 - $80,000 a year
- Full-time
- Mid-level
- Bachelor's degree
- In-person
- Health insurance
- Dental insurance
Quick Apply
8d
Continuous Improvement Engineer
EDIS Group —Coral Springs, FL
- $125,000 - $145,000 a year
- Full-time
- Engineering
- Mentoring
- Senior level
- Dental insurance
- 401(k)
Quick Apply
17h
Quality Assurance Technician
OFRA Cosmetics LLC —Pompano Beach, FL
- $16 - $18 an hour
- Full-time
- Spanish
- Analysis skills
- Continuous improvement
- Employee discount
Quick Apply
1d
Quality Engineer
Sonny's Enterprises LLC —Tamarac, FL
- Microsoft Excel
- Microsoft Outlook
- Ability to walk for extended periods
- Disability insurance
- Health insurance
QE Engineer
Apexon —West Palm Beach, FL
- $90,000 - $100,000 a year
- Full-time
- Hybrid work
- Azure
- 6 years
- AWS
- Health insurance
- Dental insurance
Quick Apply
Validation Engineer
GL Staffing Services, Inc. —Boca Raton, FL
- $70,000 - $80,000 a year
- Full-time
- Engineering
- 8 years
- In-person
Quick Apply
12d
Senior Quality Engineer
GoodLeap —West Palm Beach, FL
- $146,000 - $170,000 a year
- Full-time
- Hybrid work
- Mentoring
- Scripting
- Senior level
AS Engineer
SHL Medical —Deerfield Beach, FL
- Full-time
- Entry level
Quality Engineer Device Development
SHL Medical —Deerfield Beach, FL
- Full-time
- Pass drug screening
- Mid-level
- Criminal background check
5d
QA Engineer -Operations
SHL Medical —Deerfield Beach, FL
- Full-time
- 5 years
- Engineering
- Pass drug screening
Software Quality Assurance Engineer
ACR Electronics Inc —Fort Lauderdale, FL
- Computer science
- Microsoft Excel
- Computer Science
2d
Quality Control Engineer
AeroVironment —Sunrise, FL
- $74,500 - $105,525 a year
- Full-time
- 5 years
- Bachelor of Science
- Writing skills
- Paid holidays
- Health insurance
Senior Quality Assurance Engineer
Sabal Tech —Fort Lauderdale, FL
- Computer science
- Computer Science
- 5 years
Testing Center of Excellence (TCoE) Leader
Qualitest —Fort Lauderdale, FL
- $150,000 - $180,000 a year
- Senior level
- Leadership
- Wellness program
- Health savings account
Receiving Inspector
Willis Lease Finance Corporation —Coconut Creek, FL
- Full-time
- Microsoft Excel
- Microsoft Outlook
- English
- Health savings account
- Employee stock purchase plan
Quick Apply
Quality Engineer - Additive Manufacturing
Sintavia —Fort Lauderdale, FL
- $60,000 - $80,000 a year
- Full-time
- Mid-level
- 3 years
- Bachelor's degree
- Paid holidays
- Disability insurance
Quick Apply
8d
Quality Assurance Engineer
Dometic —Pompano Beach, FL
- Microsoft Excel
- 5 years
- Engineering
- Paid parental leave
- Disability insurance
Quick Apply
Product Quality Auditor
FHP MFG —Fort Lauderdale, FL
- Overtime
- Mid-level
- 3 years
- High school diploma or GED
Quick Apply
Precision Machine Shop Quality Manager Inspector
SoFlo Machining —Coral Springs, FL
- Mid-level
- Math
- Computer skills
Quality Assurance Engineer
Complete Turbine Services —Coral Springs, FL
- Mid-level
- Microsoft Office
- 3 years
Quick Apply

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quality engineer jobs near boca raton fl

Quality Engineer

Clinical Diagnostic Solutions, Inc.
Plantation, FL

Quick Apply

Job Details

Full-time
$70,000 - $80,000 a year
8 days ago

Benefits

Health insurance
Dental insurance
401(k)
Paid time off
Vision insurance
Life insurance

Qualifications

Teamwork
Interpersonal skills
ISO standards
Bachelor's degree
Attention to detail
Regulatory/legal compliance standards in production
Biomedical regulatory compliance
Productivity software
Quality audits
Quality systems
Cross-functional communication
FDA regulations

Full Job Description

Description

The Quality Engineer supports and executes design control, risk management, and validation activities for Class II hematology reagents and controls. This role in ensuring products and processes meet regulatory, quality, and performance requirements. The position works cross-functionally with R&D, Manufacturing, and Quality teams to support compliant product development, process validation, and lifecycle maintenance. Quality measurement trending, procedure/document review, and auditing. The position is expected to take ownership of defined design control documentation and reviews, supporting accelerated project timelines while maintaining regulatory compliance.

Job Responsibilities

· Maintain Design History Files (DHF) for reagent and control products

· Actively support development and review of: Design inputs and outputs

· Verification and validation protocols/reports

· Ensure traceability: User needs → design inputs → outputs → V&V

· Participate and host in design reviews and document meeting outputs and risk reviews.

· Support risk management activities in accordance with ISO 14971

· Review and approve (within defined scope) Validation and Qualification protocols, reports and activities

· Support validation of: Mixing tanks, filling equipment, and storage systems and Laboratory test methods (e.g., stability, bioburden, performance)

· Review document validation data in accordance with approved protocols

· Support investigations related to: Nonconformances and Out-of-specification (OOS) results

· Lead in root cause analysis and corrective actions (CAPA)

· Work with Manufacturing to ensure:

Proper implementation of SOPs
Process consistency for reagent production

· Review of Quality Documentation including Change Orders and production records. Labeling accuracy (including lot-specific data) and Material specifications

· Ensure compliance with applicable regulatory expectations for in vitro diagnostics (IVDs)

· Ensure documentation aligns with: FDA 21 CFR Part 820 and ISO 13485 Support internal and external audits by preparing documentation and responding to requests

· Identify opportunities to improve: Validation processes, Documentation clarity and compliance

· Support implementation with Quality projects and Objectives

· Support Change Order process, review and approvals.

· Participate in quality system improvements and standardization efforts

· Support internal and external audit programs

· Reviews, analyzes, and reports on quality discrepancies related to process and manufacturing

· Performs quality and regulatory tasks assigned and ensure cross training

· Participates on project teams as assigned by management.

· Performs other related duties required or as directed that are related to position

Preferred Qualifications

GMP or regulated environments

Understands and interprets regulatory, FDA, ISO and other industry standards.

Develop team culture to provide an optimum environment for employees’ growth and contribution.

Operates with appreciable latitude for actions and/or decisions on day-to-day activities. However, is expected to seek guidance on novel or controversial problems that may impact the business significantly. Demonstrated mindset of Quality as a partner and enabler to R&D and Operations

Pre-requisites/Job Experience

· Bachelors Degree in life sciences, enginerring field, or an alternative Bachelors degree program with certificate

· 2-5 years of experience in: Medical devices, diagnostics, biotech, or pharmaceutical environment. An equivalent combination of education/training and experience will be considered.

· Project experience in: Validation, lab testing, or quality systems preferred

· Self-starter with ability to manage workload with minimal direction/supervision.

· Proficient in Microsoft Office Suite

· Understanding and working knowledge of QSR/ISO regulations.

· Able to communicate both orally and in written form clearly and concisely throughout all levels within the company.

· Strong interpersonal skills.

· Ability to work within a team environment, utilize collaborative techniques, and build relationships outside of the department as well as outside the company (suppliers, regulatory agencies, etc.).

· Ability to deliver, meet deadlines, and is result orientated.

· Strong critical thinking/reasoning and problem-solving skills required to address issues in the most efficient and effective manner.

· Able to multi-task and support/prioritize projects, adapt to shifting priorities, and able to resolve problems / conflicts.

· Strong attention to detail

· Good written and verbal communication

· Ability to follow procedures while applying quality requirements pragmatically to support business needs and learn quickly

· Team-oriented with willingness to ask questions, challenge constructively and seek guidance

Physical Requirements

Must be able to lift a minimum of 25 pounds.

· Work may occasionally involve processes that require following safety precautions and use of personal protective equipment

Job Type: Full-time

Pay: $70,000.00 - $80,000.00 per year

Benefits:

401(k)
Dental insurance
Health insurance
Life insurance
Paid time off
Vision insurance

Application Question(s):

How many years of project experience in validation?

Education:

Bachelor's (Preferred)

Experience:

Medical Device: 2 years (Preferred)

Work Location: In person

Quick Apply

Refine Your Search

quality engineer jobs in boca raton fl

Quality Engineer

Continuous Improvement Engineer

Quality Assurance Technician

Quality Engineer

QE Engineer

Validation Engineer

Senior Quality Engineer

AS Engineer

Quality Engineer Device Development

QA Engineer -Operations

Software Quality Assurance Engineer

Quality Control Engineer

Senior Quality Assurance Engineer

Testing Center of Excellence (TCoE) Leader

Receiving Inspector

Quality Engineer - Additive Manufacturing

Quality Assurance Engineer

Product Quality Auditor

Precision Machine Shop Quality Manager Inspector

Quality Assurance Engineer

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