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The primary responsibility of the quality engineer is to maintain, and support compliance activities associated with product manufacturing, non-conformance reports (MRB), customer complaints, product acceptance and release through active involvement & presence in the assembly operations. Continual improvement of methods & systems towards full compliance and world class manufacturing.

Duties and Responsibilities:

• Daily support of production requirements and issues through active involvement & presence in the assembly operations and clean rooms.

• Maintain and support compliance activities associated with the Quality Management System (QMS) to comply with international and domestic regulations.

• Maintain the CAPA system and files. Coordinate CAPA activities including investigations, root cause analysis, and implementation of corrective actions with effectivity analysis.

• Develop quality assurance specifications, test devices & methods, inspection procedures, sampling plans and related written procedures.

• Support new product launch, Risk Management Activities (FMECA), Master validation plans, product V&V, Process Validations, and Design Transfer into manufacturing.

• Implement and review changes to existing products, SOPs, DOPs, Test Methods, Process Changes, Design Changes, Labeling/Labels, and Field issues to define the requirements for regulatory submissions and notifications.

• Support Internal Audit process and follow-up on Audit findings.

• Manage the Supplier Evaluation and Qualification process. Work with purchasing to manage the qualification process of new suppliers and re-evaluation of existing suppliers.

• Support & develop quality metrics and monitor production/product non-conformance trends in order to alert senior management of these trends so corrective actions can be implemented.

• Recommends modifications of existing quality or production standards to achieve optimum quality and compliance.

• Provide quality engineering support to quality control and provide guidelines on inspection methods and equipment used including measuring systems capabilities.

• Complete projects in a manner consistent with corporate objectives.

• Work with Manufacturing and Engineering teams to coordinate pilot production of new process validations and risk analysis activities.

JOB QUALIFICATION REQUIREMENTS

• Bachelor’s degree (B.S.) & Five (5) years minimum experience in quality engineering and quality assurance.

• Current knowledge of FDA Quality System Regulations and Guidelines, ISO 13485, and standards applicable to company products.

• Knowledge and understanding of Quality and Regulatory concepts and application

• Strong analytical, planning and organizational skills

• Strong interpersonal and communications skills (oral & written)

• Self-starter with ability to work independently under pressure and react quickly to changing priorities

• Proficient in MS Office products.