- 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.
- Bachelors 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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Principal Quality Engineer - Laguna Woods, United States - BioTalent
Description
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:
JOB QUALIFICATION REQUIREMENTS
