Quality Assurance Engineer, Product Quality - Med Devices

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

Job summary

Hologic, Inc. is seeking a Quality Assurance Engineer – Product Quality to manage holds, stop ships, corrections and field actions, and to develop and maintain QMS procedures.

You’ll collaborate with cross-functional teams, drive process improvements, and ensure compliance with FDA/ISO13485 standards. The role offers a base salary range of $97,600-$152,700 and bonus eligibility; equal opportunity employer.

Qualifications

• 2-4 years in QA or related regulated field.
• Hands-on with field actions, product holds, stop ships.
• Experience supporting QMS initiatives and process improvements.
• Strong root cause investigations.
• Ability to train and support quality tools usage.
• Cross-functional collaboration experience.

Responsibilities

• Manage product holds, stop ships and field actions.
• Develop and maintain QMS procedures and work instructions.
• Collaborate with cross-functional teams to improve quality processes.
• Drive corrective and preventive actions with root cause analysis.
• Provide training and guidance on quality tools and systems.

Skills

QMS procedures

Field actions

Stop ships

Corrective actions

Root cause analysis

Technical writing

Training delivery

Cross-functional collaboration

Job description

Hologic, Inc. is seeking a Quality Assurance Engineer – Product Quality to manage holds, stop ships, corrections and field actions, and to develop and maintain QMS procedures.

You’ll collaborate with cross-functional teams, drive process improvements, and ensure compliance with FDA/ISO13485 standards. The role offers a base salary range of $97,600-$152,700 and bonus eligibility; equal opportunity employer.