Quality Engineer, Medical Devices: Process Validation

Openwork; Kennesaw (GA); On-site; USD 70,000 - 75,000; Full time

Job summary

Openwork is seeking a Quality Engineer for a medical device client in Kennesaw, GA. This on-site role supports the Regulatory Affairs & Quality Assurance team across the product lifecycle, including design transfer, validation, and risk management.

Responsibilities include coordinating PFMEA/IQ/OQ/PQ activities, reviewing designs for manufacturability, and ensuring compliance with FDA and ISO 13485 requirements. Strong communication and documentation skills are essential.

Qualifications

• Experience in medical device or regulated life sciences environments.
• Strong knowledge of risk management and FDA/ISO requirements.
• Experience with design transfer, validation, and process improvement.
• Excellent documentation and cross-functional team collaboration.

Responsibilities

• Support transfer of new products into production with process validation (PFMEA, IQ, OQ, PQ).
• Assist verification/validation test plans, protocols, and reports.
• Ensure compliance with FDA and regulatory requirements.
• Participate in risk assessments, CAPAs, and supplier/customer investigations.

Skills

Quality engineering

Statistical analysis

Process validation

Risk management

Documentation/writing

Cross-functional teams

FDA/ISO knowledge

Education

Bachelor's degree in Engineering or Life Sciences

Tools

Minitab

DOE methods

Job description

Openwork is seeking a Quality Engineer for a medical device client in Kennesaw, GA. This on-site role supports the Regulatory Affairs & Quality Assurance team across the product lifecycle, including design transfer, validation, and risk management.

Responsibilities include coordinating PFMEA/IQ/OQ/PQ activities, reviewing designs for manufacturability, and ensuring compliance with FDA and ISO 13485 requirements. Strong communication and documentation skills are essential.