Sr. Quality Engineer

Job Summary:

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
• Strong verbal and written communications skills.
• Able to multi-task and set priorities based on business needs.
• 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

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