Senior Film Quality Engineer: QMS, Validation & Analytics

AptarGroup, Inc.; Auburn (AL); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

401K plan

Vacation

Medical, dental, vision

Life and disability

Pet insurance

Wellness plan

Maternity/paternity leave

Job summary

AptarGroup, Inc. in North America invites applications for a Film Quality Engineer III, based in Auburn, AL. You will lead quality systems, audits, CAPA, risk management, and data-driven improvements in a fast-paced medical device packaging environment.

The role requires strong regulatory knowledge, statistical analysis, and cross-functional leadership to ensure product quality, process capability, and regulatory compliance across global facilities.

Qualifications

• Bachelor's degree in Engineering, Science, or related field required.
• ASQ CQE certification preferred.
• Strong knowledge of statistical methods and quality data analysis.

Responsibilities

• Ensure compliance with Quality Management System and regulatory requirements.
• Lead audits and support CAPA investigations and corrective actions.
• Lead risk management activities per ISO 14971 and related standards.
• Provide technical leadership in study design, statistics, and data interpretation.
• Develop, document, and improve quality procedures and work instructions.
• Coordinate documentation review and release for production and sample batches.
• Mentor cross-functional teams on quality systems and documentation.

Skills

Quality systems

Regulatory knowledge

Statistical analysis

CAPA management

Cross-functional leadership

Root cause analysis

Documentation control

Project management

Auditing

Education

Bachelor's degree in Engineering, Science, or related field

ASQ CQE certification (preferred)

Tools

SAP

ERP systems

MES

Job description

AptarGroup, Inc. in North America invites applications for a Film Quality Engineer III, based in Auburn, AL. You will lead quality systems, audits, CAPA, risk management, and data-driven improvements in a fast-paced medical device packaging environment.

The role requires strong regulatory knowledge, statistical analysis, and cross-functional leadership to ensure product quality, process capability, and regulatory compliance across global facilities.