Quality Assurance Engineer

Responsible for ensuring that the products produced meet quality standards required to minimize quality costs and maximize customer satisfaction, whilst ensuring that procedures and processes are adhered to. Ensure incoming materials meet required quality standards. Responsible for identifying and raising quality issues and for speedily resolving them to ensure zero impact to the customer. Support new product introductions to ensure the robustness of product builds. Work in a team environment to develop and implement best practices that emphasize defect prevention, reduction in variation and waste and provide for continuous improvements in meeting all customer requirements. Manage the customer-specific requirements and offer technical support. Responsible for multiple highly complex major projects requiring innovative original solutions, where results are key to the successful completion of major projects. Work mostly independently with minimal supervision, and work is reviewed at project milestones and/or on completion by Senior Management.

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 the 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 SQF
• Work directly with the Plant Manager 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.)
• 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 determine methods for new assignments and provide guidance to other personnel
• Strong verbal and written communication skills.
• Able to multitask 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
• Excellent organizational skills and attention to detail.

• Extensive knowledge of or the ability to quickly learn production processes.
• Excellent interpersonal skills with the ability to serve as a liaison with developers, project managers, customers, and customer support.
• Thorough understanding of federal, state, local, and industry standards, guidelines, and regulations.
• Strong analytical and problem-solving skills.
• Proficient with Microsoft Office Suite or related software.