Medical/Food Packaging Material Sr Quality Engineer

The Senior Quality Engineer will provide experienced quality assurance support to the product development team, resolving bugs, defects, and other issues and ensuring the product meets customer specifications.

Responsibilities:

• Perform in-process and new product verification and validation activities.
• Address all Non-conformances and lead all corrective actions for customer complaints.
• Promote continuous improvement in quality, process control, and material efficiency through use of statistical techniques to quantify and analyze plant & systems capabilities
• Develop Quality Training for facility.
• Review and Revise Risk management plan, HACCP Plan, Management Goals and objectives for ISO and SQF.
• Prepare inspection instructions, systems and procedures.
• Perform statistical analysis of various process parameters and/or test results of both finished products and subassembly products.
• Head Auditee or Auditor for all Quality System Standards and Regulations, FDA, supplier, customer and internal audits as required.
• Oversee Quality related ISO Class 4 and ISO Class 7 cleanroom operations.
• Work directly with the Director of Quality on continuous improvement and development of quality assurance system.
• SQF Practitioner for facility and maintain SQF Certification.
• ISO 9001-2015 Representative for facility and maintain ISO 9001:2015 Certification
• Ensure sustainability of ISO and SQF quality management system by reviewing and revising documents, inspecting activities on floor as per procedure and work instructions.
• Lead New Product Development and Validation of new products.

Qualifications:

• Bachelor’s degree in Engineering (or Technology). Graduate coursework is desirable.
• Minimum of 5 years of experience possessing broad experience and knowledge of Supplier Quality used to contribute to the development of company objectives and principles.
• Solid experience in developing and maintaining Quality Systems and monitoring Quality in a manufacturing environment (medical or food related preferable).
• Knowledge and Experience in manufacturing processes (i.e. Flexible Printing, Lamination, Converting, etc.)
• Able to read Mechanical Drawings (including GD&T) and Specifications.
• ASQ Certification as a Certified Quality Engineer (CQE) is strongly preferred.
• Trained and Certified Six Sigma Green Belt, or higher, is desirable.
• Solid experience in performing Supplier Quality Systems Audits and Monitoring Supplier Performance.
• Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results.
• Able to determines methods on new assignments and provide guidance to other personnel
• Adept at using Windows based computer programs such as Word and Excel. Experienced with collaboration tools such as Microsoft Teams, OneNote, SharePoint 365, etc.
• Able to work on problems of diverse scope where analysis of data or situations requires evaluation of identifiable factors
• Able to travel domestically and internationally--10% travel, mostly domestic.