Principal Quality Engineer

4 weeks ago

Laguna Woods, United States BioTalent Full time

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.

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