QA Engineer – Product Quality (Medical Devices)

DIRECT SALES, US; Marlboro (MA); On-site; USD 98,000 - 153,000; Full time

Job summary

Hologic is seeking a Quality Assurance Engineer – Product Quality to ensure safety and reliability of life-saving medical devices. You will manage product holds, stop ships, and field actions while developing and maintaining QMS procedures.

The role requires collaboration with multiple functions to drive corrective actions and process improvements in a regulated environment. The position emphasizes proactive quality leadership, thorough investigations, and clear technical writing to document

Qualifications

• Strong understanding of Quality Management Systems (QMS) and regulatory requirements.
• Experience with field actions, holds and stop ships.
• Knowledge of corrective/removal action processes and root cause investigations.
• Ability to document progress, track closure of records, and create training materials.

Responsibilities

• Develop and maintain QMS procedures and work instructions for holds, stop ships, and corrections/removals.
• Plan, execute, and monitor field actions, recalls, and corrective actions.
• Collaborate with corporate process owners, external vendors, and cross-functional teams.
• Provide training and guidance on quality tools and systems.

Skills

QMS Procedures

FDA/ISO 13485

Root cause analysis

Cross-functional collaboration

Process improvement

Technical writing

Training and guidance

Job description

Hologic is seeking a Quality Assurance Engineer – Product Quality to ensure safety and reliability of life-saving medical devices. You will manage product holds, stop ships, and field actions while developing and maintaining QMS procedures.

The role requires collaboration with multiple functions to drive corrective actions and process improvements in a regulated environment. The position emphasizes proactive quality leadership, thorough investigations, and clear technical writing to document