Abbott Senior Quality Engineer - Packaging, Supplier Quality Assurance - Columbus OH in Columbus, Ohio
At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
The primary function of the Packaging Supplier Quality Assurance group (SQA) is to assure a high-quality supply of packaging materials through evaluation and development of Abbott Nutrition suppliers world wide. Packaging SQA is responsible for working and communicating with suppliers as part of an ongoing supplier management process. Packaging SQA supports systems such as: package and supplier qualification, packaging regulatory documentation and continuous improvement of suppliers’ performance. In addition, Packaging Supplier QA supports the plant quality assurance, operations and purchasing groups globally to ensure that proper incoming material documentation involving CAPA, testing/release, acceptance plans and specifications are compliant to Corporate and regulatory requirements.
The Sr. Quality Engineer, Packaging SQA should exhibit excellent communication and leadership skills and support the training and development of Associate Project Leaders and Project Leaders in the department. The Sr. Project Leader will be expected to manage more projects with a larger scope and complexity. Responsibilities include:
• Perform supplier qualification assessments of new packaging suppliers to assure the quality design of the package and the supplier’s processes, facilities and systems meet AN and regulatory requirements.
• Work with Package Development to develop, validate and issue packaging methodology and equipment. Conduct equipment R&R studies at qualification to assure that testing between plant and suppliers is in alignment.
• Develop packaging suppliers’ systems and processes to improve process capability and to develop certificates of analysis. Assure appropriate supplier in-line equipment is validated.
• Conduct reviews and updates to supplier regulatory documentation that is submitted with all packaging changes and new qualifications to assure regulatory compliance.
• Responsible for maintaining/controlling the approved supplier status of suppliers.
• Maintain relevant documentation such as PQE policies, procedures, specifications, and acceptance programs and assure these documents are current and compliant to internal policies and regulations.
• Assure that proposed changes made to supplier processes are approved and compliant to specifications, making changes when necessary.
• Provide support to global operations by resolving packaging material issues in a timely manner. Work with plants to develop sampling and correction plans when resolving packaging issues within received lots.
• Manage packaging supplier recurring CAPAs on a monthly, quarterly and annual basis by evaluating exception report data and reporting information to appropriate areas of the business (i.e. Purchasing and Operations), as well as the suppliers.
• Support resolution and approval of exception reports within the plants. Lead investigations to resolve and troubleshoot supplier processing or packaging issues.
Bachelor of Science degree in technical or science field required.
The Sr. Quality Engineer should have at least 8-10 years of experience in quality, packaging engineering, supplier quality assurance programs or related experience in operations, or quality assurance. The Sr. Quality Engineer should meet and/or exceed the Abbott Core Competency requirements, as well as:
Possess a thorough knowledge of manufacturing processes (production, logistics, and engineering) and quality assurance principles.
Possess technical understanding of different technologies, product quality systems and supplier programs and be able to provide consultation and recommendations to help suppliers improve their performance.
Possess an understanding of food packaging laws and regulated industry for commercial packaging.
Have experience in performing/leading supplier assessments and working independently through troubleshooting supplier issues.
Have the ability to successfully interact and communicate with all organizational levels internally and with leadership.
Demonstrate the ability to manage several activities / projects at once, to organize / prioritize work, to meet deadlines and to prepare plans and reports.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email firstname.lastname@example.org