Quality Assurance Engineer III, Medical Devices

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

Job summary

Hologic, Inc. in the United States is seeking a Quality Assurance Engineer - Product Quality to manage product holds, stop ships, corrections, and field actions, while developing and maintaining QMS procedures and driving cross-functional collaboration to ensure compliance and efficiency.

You will contribute to continuous improvement of product quality, perform root cause analyses, document investigations, train teams, and support lifecycle processes in a regulated medical device environment.

Qualifications

• Experience with field actions, holds, stop ships, and corrections/removals in a regulated environment.
• Strong knowledge of QMS procedures and regulatory requirements (FDA/ISO 13485).
• Proven ability to collaborate with cross-functional teams on quality initiatives.
• Demonstrated capability to lead investigations and implement corrective actions.
• Experience providing training and guidance on quality tools and systems.

Responsibilities

• Manage product holds, stop ships, corrections, and field actions.
• Develop and maintain QMS procedures and work instructions.
• Collaborate with corporate process owners and vendors on quality initiatives.
• Lead investigations and drive root cause analysis and corrective actions.
• Document progress, track closure of records, and prepare training materials.

Skills

QMS implementation

Field action management

Root cause analysis

Cross-functional collaboration

Technical writing

Training and guidance

Tools

QMS software

Job description

Hologic, Inc. in the United States is seeking a Quality Assurance Engineer - Product Quality to manage product holds, stop ships, corrections, and field actions, while developing and maintaining QMS procedures and driving cross-functional collaboration to ensure compliance and efficiency.

You will contribute to continuous improvement of product quality, perform root cause analyses, document investigations, train teams, and support lifecycle processes in a regulated medical device environment.