Top 31683 Validation Engineer Jobs

Quality Engineer
Drummond Scientific Company —Broomall, PA
- $82,000 a year
- Full-time
- Background check
- Engineering
- Analysis skills
- Health insurance
- Dental insurance
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Certification Engineer
Rotork —Winston-Salem, NC
- Full-time
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- Travel
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Senior Quality Engineer
Calnetix Technologies, LLC —Cypress, CA
- From $130,000 a year
- Full-time
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- 8 years
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High-Speed Design validation Engineer
Capgemini —San Francisco, CA
- Full-time
- 7 years
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Sr. Process Engineer
Alcami Corporation —Charleston, SC
- Full-time
- Microsoft Excel
- Microsoft Outlook
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Validation Engineer
VERAZ INC —Boston, MA
- $30 - $45 an hour
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- 1 year
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- Relocation assistance
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Computer System Validation Engineer
Katalyst Healthcares & Life Sciences —New Wilmington, PA
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SSA Tech —Herndon, VA
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Sebela Pharmaceuticals Inc. —Holbrook, MA
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ALLIANCE BIOTECH SOLUTIONS LLC —Raleigh, NC
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System QA Engineer
TMP Worldwide India Private Limited for ERS US —Cupertino, CA
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- Email
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Fresenius Kabi —Warrendale, PA
- $85,000 - $100,000 a year
- Full-time
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- Bachelor of Science
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Electronics and Hardware Test Engineer
Hudson Manpower —Greenville, SC
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Medline Industries —Hartland, WI
- $73,000 - $110,000 a year
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HEALTHPLANONE, LLC —Tampa, FL
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Pharma-Bio Serv —Dorado, PR
- Contract
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Validation Engineer
Weiss-Aug MedPharma —Fairfield, NJ
- $100,000 - $110,000 a year
- Full-time
- Microsoft Excel
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Validation Engineer I
LG Electronics —Aliso Viejo, CA
- $57,787 - $77,050 a year
- Full-time
- Bachelor of Science
- Engineering
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Validation Engineer
The Assurance Group —Pine Brook, NJ
- $75,000 - $85,000 a year
- Full-time
- Microsoft Excel
- Microsoft Outlook
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11d
Design Validation Engineer II
Recaro Aircraft Seating Americas, Inc. —Fort Worth, TX
- Full-time
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11d

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Quality Engineer

Drummond Scientific Company -
Broomall, PA

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Job Details

Full-time
$82,000 a year

Benefits

Health insurance
Dental insurance
401(k)
Paid time off
Parental leave
Employee assistance program
Vision insurance
401(k) matching
Life insurance
Retirement plan

Qualifications

Statistics
Defect resolution root cause analysis
Preventive action implementation
Engineering
Statistical Process Control
Corrective and preventive actions (CAPA)
GMP
ASQC Certification
Bachelor's degree in engineering
Bachelor's degree
Medical device manufacturing facility experience
Attention to detail
Process validation (IQ/OQ/PQ)
Biomedical regulatory compliance
Root cause analysis
PPAP
Process management
ISO 13485
FDA regulations
Customer complaint resolution
Failure analysis

Full Job Description

*Applicants must be authorized to work in the U.S. without current or future visa sponsorship.

*This role is fully on-site and based in Broomall, PA. We are unable to offer relocation assistance for this role.

Company:

Drummond Scientific Company, located just outside of Philadelphia, PA, is a family-owned company that leverages nearly 75 years of experience to maintain its position as an elite developer and manufacturer of consumable medical devices, which includes both microvolume liquid transfer technology and rapid diagnostics. Our branded products can be found in laboratories across the globe and are continuously recognized for their durability and reliability. Despite the notoriety gained from the products bearing the Drummond name, what truly establishes the company as an industry leader is its role as a contract manufacturer. Parts made by Drummond have helped create and save lives by revolutionizing the field of in vitro fertilization and enabling the diagnostic technologies of many of the largest, and most innovative, companies in the world.

Scope of Position

The Quality Engineer ensures that all medical devices are designed, manufactured, and distributed in compliance with FDA 21 CFR Part 820, ISO 13485, and other applicable regulatory and customer requirements. This role drives product quality, process capability, and continuous improvement across the manufacturing lifecycle, supporting both new product development and ongoing production.

Key Responsibilities

Maintain and improve the Quality Management System (QMS) in alignment with ISO 13485, FDA QSR, and internal procedures.
Lead and support internal audits, supplier audits, and regulatory inspections.
Own and manage quality system elements such as CAPA, NCRs, complaint handling, and document control.
Develop, validate, and monitor manufacturing processes using statistical tools (SPC, DOE, MSA).
Support production teams in resolving quality issues, identifying root causes, and implementing corrective and preventive actions.
Create and maintain inspection plans, sampling plans, and quality control documentation.
Participate in design reviews, ensuring compliance with Design Control requirements.
Support verification and validation (V&V) activities, including test method validation.
Evaluate and qualify suppliers; maintain supplier performance metrics.
Review and approve supplier PPAPs, first article inspections, and material certifications.
Drive supplier corrective actions and continuous improvement initiatives.
Analyze quality data to identify trends, process capability, and improvement opportunities.
Prepare quality reports for management, including KPIs, audit findings, and CAPA status.
Use statistical software (e.g., Minitab) to support data-driven decision-making.

Qualifications

Bachelor’s degree in engineering (Mechanical, Biomedical, Industrial, or related field).
2–5 years of experience in a regulated manufacturing environment; medical device experience strongly preferred.
Working knowledge of ISO 13485, 21 CFR Part 820, ISO 14971, and GMP.
Experience with CAPA, root cause analysis tools (5 Whys, Fishbone), and process validation (IQ/OQ/PQ).
Proficiency with statistical analysis and quality tools (SPC, MSA, DOE).
ASQ certifications (CQE, CQA) are a plus.

Desired Skills & Abilities

Strong analytical and problem‑solving skills.
Ability to interpret engineering drawings and specifications.
Excellent communication and cross‑functional collaboration.
Detail‑oriented mindset with a commitment to product safety and compliance.
Ability to manage multiple priorities in a fast‑paced environment.

Travel Requirements

Travel will be <5%

Employment Type

Full-time

Pay: $82,000.00 per year

Benefits:

401(k)
401(k) matching
Dental insurance
Employee assistance program
Health insurance
Life insurance
Paid time off
Parental leave
Retirement plan
Vision insurance

Application Question(s):

Will you now, or in the future, require sponsorship for employment visa status (e.g. H-1B visa status)?

Experience:

medical device manufacturing: 3 years (Required)
ISO 13485, 21 CFR Part 820, ISO 14971, and GMP: 1 year (Required)

Ability to Commute:

Broomall, PA 19008 (Required)

Work Location: In person

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Refine Your Search

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Quality Engineer

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Equipment Validation Engineer

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