Film Quality Engineer III

Aptar Italia S.P.A.; Auburn (AL); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

401K plan

Vacation & Paid time off

Medical, dental, vision benefits

Life and disability insurance

Maternity/paternity leave

Job summary

Aptar in Auburn, AL is seeking a Film Quality Engineer III to join the R&D and Quality Lab team. You will enforce Aptar’s QMS, lead audits, manage CAPAs, and drive quality improvements across processes, equipment, and products.

The role requires strong ISO 13485 knowledge, risk management (ISO 14971), statistical methods, and ability to mentor cross-functional teams. A Bachelor's degree in Engineering or Science is required; SAP experience is a plus.

Qualifications

• Knowledge of ISO 13485, FDA QMSR and regulatory requirements.
• Ability to lead audits and cross-functional teams in QA.
• Experience with CAPA investigations and corrective actions.
• Strong data analysis and statistical methods for quality decisions.
• Proven ability to mentor engineers and drive continuous improvement.

Responsibilities

• Enforce Aptar Quality Management System across regulatory and customer requirements.
• Lead risk management activities per ISO 14971 and industry best practices.
• Manage CAPAs, investigations, and data-driven improvement strategies.
• Develop validation protocols and oversee IQ/OQ/PQ activities.
• Mentor cross-functional teams in quality methodologies and documentation.

Skills

ISO 13485

QMSR

Risk management

Statistical analysis

CAPA

Auditing

QA leadership

Education

Bachelor’s degree in Engineering or Science

Tools

SAP

ERP systems

MES platforms

Job description

Select how often (in days) to receive an alert: Create Alert

WHO ARE WE

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.

YOU SHOULD WORK HERE BECAUSE WE:

• 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.

WHAT’S NEW WITH APTAR

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.

THIS IS HOW YOUR JOURNEY BEGINS

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 Safety (EH&S) procedures including work instructions and associated forms and deploy all personal protective equipment (PPE) such as gowning attire, safety glasses, gloves, respirators and hearing protection as required.
• Demonstrate the willingness and drive to do what it takes to get the job done.
• Ensure products and manufacturing processes meet established quality standards by defining and implementing inspection, testing, and validation requirements for equipment, processes, and materials to support compliance with product specifications and regulatory requirements.
• Lead cross-functional efforts to develop, standardize, and optimize procedures, work instructions, and process documentation for new and existing processes. Ensure documentation aligns with business objectives, quality system requirements, regulatory standards, and industry best practices. Drive continuous improvement initiatives, oversee complex document change activities, and mentor team members on document control, process standardization, and quality system expectations.
• Perform root cause analysis using structured methodologies, collaborate cross-functionally
  with Operations teams to identify corrective and preventive actions, and ensure timely and
  accurate completion of complaint records, investigation reports, and supporting
  documentation
• Communicate investigation findings and resolutions clearly to internal stakeholders and customers as needed. Monitor effectiveness of corrective actions, ensuring closure of complaints within established timelines and timely responsive support to customers.
• Coordinate, review, and release all production and sample batch documentation to ensure compliance to product specifications or customer requirements, in addition to good documentation practices, cGMPs and other applicable requirements, prior to shipping to the customer.
• Trend and analyze internal and external complaint data to identify recurring issues and opportunities for continuous improvement. Communicate under performance and ...
• Manage and provide oversight into the intake, documentation, and resolution of customer complaints in accordance with company procedures and regulatory requirements.
• Lead the development, execution, and approval of qualification protocols and/or engineering studies for products, processes, equipment, and systems.
• Provide technical leadership in study design, test method selection, statistical analysis, and interpretation of results to ensure testing activities generate reliable and scientifically sound evidence supporting product performance, process capability, regulatory compliance, customer satisfaction, and business objectives. Serve as a key technical resource for complex investigations, validation activities, and continuous improvement initiatives.
• Participate in the execution of long-range goals, strategies, plans and policies as they relate to the management of quality systems for the Medical Device business unit.

WHAT YOU WILL BRING ON THE JOURNEY

• Bachelor’s degree in Engineering, Science, or a related field; or equivalent combination of education and relevant work experience.
• ASQ Certified Quality Engineer (CQE) certification or other relevant, advanced levels of achievement is preferred.
• Proficiency in use of statistical and other analytical tools.
• Advanced proficiency in Microsoft Office applications, including Excel, Word, PowerPoint, and Outlook, with the ability to develop complex data analyses, dashboards, reports, presentations, and technical documentation to effectively communicate quality performance, project status, and strategic recommendations to cross-functional teams and leadership.
• SAP experience preferred
• Experience with or the ability to demonstrate advanced proficiency with quality management, enterprise resource planning (ERP), and manufacturing execution systems (MES) platforms. Ability to leverage system data to support quality system compliance, process monitoring, investigations, trend analysis, performance reporting, and continuous improvement initiatives. Serves as a resource for system-related process improvements and cross-functional implementation activities.
• Demonstrated time management and prioritization skills, the ability to work as a team, and the ability to communicate effectively to others.
• Demonstrated ability to self-manage, problem solve and take full ownership of work with minimal oversight.
• The ideal candidate must be able to complete all physical requirements of the job with or without a reasonable accommodation.
• The ideal candidate must also have a demonstrated ability to successfully lead and prioritize multiple complex projects and quality initiatives concurrently in a fast-paced environment, balancing competing priorities while ensuring timely execution, regulatory compliance, and achievement of business objectives.

WHAT WE OFFER:

• Competitive base salary and performance-based bonus plan.
• An Exciting, Diverse and value based working environment
• Award-winning Corporate University offering personal development and training opportunities.
• Innovative benefits plan which includes: 401K plan, vacation, medical, dental, vision, life, disability, petinsurance, wellness plan, and generous paid maternity/paternity leave.
• Retirement Savings plan

Be You. Be Aptar Aptar

is an equal opportunities employer. We believe that a diverse workforce is key to our success. We welcome applications from all members of society irrespective of age, sex, disability, sexual orientation, race, religion or belief.

Nearest Major Market: Auburn
Nearest Secondary Market: Opelika