Quality Assurance Engineer III - Medical Devices, QMS Lead

Hologic, Inc.; Marlborough (MA); On-site; USD 98,000 - 153,000; Full time

Job summary

Hologic, Inc. in Marlborough, MA, seeks a Quality Assurance Engineer - Product Quality to manage product holds, stop ships, corrections and field actions.

You will develop and maintain QMS procedures, collaborate with cross-functional teams, and drive process improvements to ensure compliance and efficiency. Ideal candidates will have 2–4 years in QA or related regulated environments, hands-on experience with field actions and corrective actions, plus strong technical writing and root cause

Qualifications

• Strong understanding of QMS and regulatory requirements.
• Experience with field actions, holds, stop ships.
• Knowledge of FDA regulations and ISO 13485.
• Root cause analysis and corrective actions.

Skills

QMS procedures

Field actions

Corrections/Removals

Cross-functional

Technical writing

Root cause analysis

Process improvement

Quality tools training

Training delivery

Job description

Hologic, Inc. in Marlborough, MA, seeks a Quality Assurance Engineer - Product Quality to manage product holds, stop ships, corrections and field actions.

You will develop and maintain QMS procedures, collaborate with cross-functional teams, and drive process improvements to ensure compliance and efficiency. Ideal candidates will have 2–4 years in QA or related regulated environments, hands-on experience with field actions and corrective actions, plus strong technical writing and root cause