Film Quality Engineer III

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At Aptar, we use insights, design, engineering and science to create innovative packaging technologies that build brand value for our customers, and, in turn, make a meaningful difference in the lives, looks, health and homes of people around the world. Every day, Aptar creates “a-ha moments” for its customers and their consumers and patients by continually bringing innovations to market that convert non-dispensing packaging into breakthrough product-dispensing systems, including those that give people more effective ways to put on their favorite fragrance, kids the opportunity to pour ketchup without making a mess and patients connected technologies that help them more easily adhere to treatment.

We have manufacturing facilities in North America, Europe, Asia and South America and over 13,000 dedicated employees in 18 different countries.

• attract and develop high performing people.
• promote a diverse and inclusive work environment.
• allow for failure by allowing people to make mistakes through an open and trusting environment.
• invest in the development of employees through local, regional and global career opportunities.
• contribute to the communities where we reside.

We have an exciting position open in North America:
Film Quality Engineer III, reporting to the R&D and Quality Lab Director. This position will be based in Auburn, AL.

Responsibilities:
Include but are not limited to the following:

• Ensure enforcement and compliance with Aptar’s Quality Management System in accordance with all regulatory, legal and business requirements, and any Customer Specific Requirements.
• Demonstrate advanced knowledge of ISO 13485, FDA 21 CFR Part 820 / Quality Management System Regulation (QMSR), and other applicable regulatory, industry, and customer requirements and proven ability to lead and support the associated audits. Serve as a quality resource to cross-functional teams by interpreting regulatory requirements, assessing compliance risks, supporting quality system improvements, and ensuring processes, procedures, and products consistently meet applicable standards and regulatory expectations.
• Demonstrate advanced knowledge and application of risk management principles in accordance with ISO 14971 and industry best practices. Lead and facilitate risk management activities, including risk analysis, risk evaluation, risk control, and residual risk assessment.
• Serve as a subject matter expert in statistical methods and quality data analysis, applying advanced analytical techniques to evaluate process performance, identify systemic quality issues, assess process capability, and drive risk-based decision-making. Lead complex root cause investigations, develop data-driven improvement strategies, and mentor engineers and cross-functional teams in the effective use of statistical tools and quality methodologies.
• Proven ability to strategize and lead complex CAPA investigations and drive systemic corrective actions and/or continuous improvement programs
• Proven ability to strategize and lead complex validation programs for equipment, processes, software, and systems by developing validation strategies, authoring and approving IQ/OQ/PQ protocols and reports, assessing validation risks, resolving complex validation issues, and ensuring compliance with applicable quality, regulatory, and industry standards. Provide technical leadership and mentorship to quality and cross-functional teams regarding validation principles and best practices.
• Demonstrate good verbal and written communication skills, as well as attention to detail.
• Adhere to all Environmental Health and…