Quality Engineer

Kaygen, Inc.

Covington (GA)

On-site

USD 75,000 - 95,000

Full time

32 hours ago

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Benefits offered by this job

Free Healthcare Insurance

401(k) Retirement Plan

Free Life Insurance

Sick Time Off

Certifications

Referrals

Family and Wellness benefits

Continuous Growth and Career Developm

Job summary

Kaygen, Inc. is seeking a Quality Engineer III to support a distribution of medical devices and pharmaceuticals in Covington, GA.

The role focuses on maintaining the quality management system, ensuring compliance with GMP/GDP standards, and leading or supporting supplier qualifications, calibration, and validation efforts. The ideal candidate has 2–3 years in quality engineering in medical devices/pharma, knowledge of ISO 13485 and FDA regulations, and experience with ERP systems.

Qualifications

2–3 years of experience in quality engineering within distribution or manufacturing of medical devices or pharmaceuticals.
Strong problem-solving and analytical skills.
Experience with ERP systems and regulatory standards (FDA/ISO 13485).

Responsibilities

Provide engineering support to maintain a quality management system aligned with medical device/pharma distribution.
Lead validation, calibration, IQ/OQ/PQ protocol activities for equipment and processes.
Support audits and compliance readiness, investigations, corrective actions, and change control.

Skills

Quality engineering

Problem solving

ERP systems

FDA regulations

ISO 13485

Education

ASQ CQA or CQE certification

Job description

KAYGEN is an emerging leader in providing top talent for technology-based staffing services. We specialize in providing high-volume contingent staffing, direct hire staffing and project-based solutions to companies worldwide ranging from startups to Fortune 500 and Managed Service Providers (MSP) across a wide variety of industries.

Job Description

Job Title: Quality Eng 3

Location: Covington, GA 30014

Duration: 12-month contract with possible extensions

Job Description

Responsibilities

Provide engineering support to maintain a comprehensive quality management system, tailored to the distribution of medical devices and pharmaceuticals.
Ensure systems are in line with Good Distribution Practices, ISO13485 and other relevant regulatory standards.
Provide statistical data analysis in support of investigations and continuous improvement projects.
Lead or participate in qualifying suppliers within calibration, validation or temperature monitoring processes.

Quality Operations Oversight

Monitor quality control processes in change control, temperature monitoring and validations including implementing continuous improvement strategies.

Validation and Calibration Expertise

Lead validation efforts for distribution equipment, processes, and software, ensuring accuracy and reliability, including IQ/OQ/PQ protocol writing, execution and approval of protocols.
Oversee the calibration of critical instrumentation to maintain precise measurements and controls, including OOT investigations
Manage validation vendors to ensure on time calibrations, at multiple sites, of all critical equipment.
Monitor Environmental conditions at Distribution Centers to protect product integrity.
Implement and manage controls for temperature, humidity, and other critical parameters.
Implement and manage shipping lane controls to ensure product integrity is safeguarded throughout the shipping process.

Audit and Compliance Readiness

Prepare for and support both internal and external audits.
Address audit outcomes swiftly and effectively to maintain compliance.

Quality Incident Investigation

Spearhead investigations into any quality deviations, non-conformances, or customer complaints.
Implement corrective actions to prevent recurrence and enhance quality.
Directly participate in quality investigations, including owning those investigations to closure.
Act as a reviewer and approver of quality investigations

Document and Change Management

Maintain controlled procedures within calibration, validation, environmental controls, change control and risk management.
Ensure data from environmental controls is maintained in centralized repository.
Manage change control processes to ensure seamless transitions and compliance.
Lead change control process for designated sites.

Required Qualifications

2-3 years of experience in quality engineering, within a distribution center or manufacturing of medical devices or pharmaceuticals.

Preferred Qualifications

ASQ CQA or CQE certification
Experience with Boards of Pharmacy, licensing, and regulatory submissions
Experience as a designated representative with state boards of pharmacy
2-3 years’ experience with ISO 13485, certification preferred

Skills

Excellent problem-solving skills with the ability to think critically and creatively.
Experience working with ERP systems.
Knowledge of FDA regulations and ISO standards related to medical device manufacturing.
2- 3 years’ experience with ISO 13485, certification preferred

Shift: ["1-3 years' experience in medical device or pharmaceutical manufacturing", '1-3 years validation experience in medical device or pharmaceutical industries']

At KAYGEN, people are at the heart of everything we do. We foster a diverse, inclusive, and employee-driven culture where every individual is valued, empowered, and encouraged to bring their authentic self to work. Our candidate-first approach means we are committed to understanding your career goals and connecting you with opportunities that align with your aspirations, skills, and potential. Whether you're taking the next step in your career or searching for your dream opportunity, KAYGEN is more than a staffing partner— we're a community dedicated to helping you grow, succeed, and thrive. Join us and discover a place where your talent is recognized, your ambitions are supported, and your future is built alongside a team that invests in your success every step of the way.