Katalyst Healthcares and Life Sciences
Quality Engineer II
Katalyst Healthcares and Life Sciences, Woodland, California, United States, 95776
Job Description:
Develop and support all Quality Management System (QMS) / Regulatory Affairs (RA) activities and functions supporting the quality goals and quality metrics for site. Responsible for new product setup, quality project management, and regulatory compliance of serum products. Ensure compliance to in-house and/or external specifications and standards such as cGMPs, 21 CFR 820, ISO 13485, and Quality System Procedures. Responsibilities:
Ensure compliance to new and changing regulations affecting products and processes including, but not limited to, QSR's, global import/export regulations, etc. New product setup and management of related projects ssist with Supplier audits, as needed Collaborates with USDA on regulatory compliance activities including regulatory approvals, import/export compliance, traceability, quarantine, safety testing and affidavits. Serve as a resource for customer's regulatory and technical inquiries Ongoing maintenance of ISO 13485 based quality system Implement and handle CAPA (Corrective and Preventive Actions) and problem resolution. Coordinates and leads Quality Documentation, Nonconformance Reports, Inspection ctivities and Product Disposition. Coordinates the review and revision of procedures, specifications, and forms to maintain and improve the QMS. Quality Help Desk and customer complaint point of contact and problem resolution including Questionnaires, Certificates and Customer Surveys, etc. Perform Internal Audits in support of internal requirements, 21 CFR 820 and ISO 13485 compliance. ssists in representing in customer quality audits, supplier quality audits and regulatory inspections Performs investigations and analysis activities to support resolution of quality issues. Collaborates with organizational teams to support quality system implementation. Creation of new product master files satisfying customer and quality system requirements Ensures quality standards by following company & departmental policies & procedures including, but not limited to: Product performance & quality verification. Identifying, recording, and investigating problems related to product, process & quality systems. Evaluating processes for improvements and standardization. Initiating action to prevent non-conformance in products, process, and quality systems. Training on quality systems and applicable regulations as identified by supervisor and required by position. Tracking/trending aspects of the QMS. Other job duties as required. Requirements:
Minimum of bachelor's degree in science, Engineering, Bioengineering or related field. Prefer Chemistry or Biology degree programs. Preferred Education, Years and Area of Experience. Minimum 3 years' experience in Quality or Regulatory, preferably in a medical device, pharmaceutical or biotechnology environment/industry. Thorough knowledge and practical application of Quality Systems Regulations 21 CFR 820 and ISO 13485 bility to develop, update and train on SOPs. Working knowledge of ISO standards and Quality Management Systems (QMS). Problem solving techniques to perform investigations and drive root cause analysis. Related work experience performing internal/external audits. bility to monitor the QMS such as: Change Control, CAPA, Complaints, Nonconforming Materials and Products. Experience with Continuous Improvement, Lean or Six Sigma. Desired Experience / Qualifications / Skills: SAP, ETQ and/or PeopleSoft experience. Experience with statistical analysis. Project management experience. nimal by-product import/export regulations nimal health and/or virology, immunology, epidemiology knowledge bility to multi-task with ability to be organized. Strong interpersonal and communication skills. Strong time management skills and attention to detail. bility to influence others in a team environment while collaborating with peers and functional areas. bility to work independently with minimal supervision.
Develop and support all Quality Management System (QMS) / Regulatory Affairs (RA) activities and functions supporting the quality goals and quality metrics for site. Responsible for new product setup, quality project management, and regulatory compliance of serum products. Ensure compliance to in-house and/or external specifications and standards such as cGMPs, 21 CFR 820, ISO 13485, and Quality System Procedures. Responsibilities:
Ensure compliance to new and changing regulations affecting products and processes including, but not limited to, QSR's, global import/export regulations, etc. New product setup and management of related projects ssist with Supplier audits, as needed Collaborates with USDA on regulatory compliance activities including regulatory approvals, import/export compliance, traceability, quarantine, safety testing and affidavits. Serve as a resource for customer's regulatory and technical inquiries Ongoing maintenance of ISO 13485 based quality system Implement and handle CAPA (Corrective and Preventive Actions) and problem resolution. Coordinates and leads Quality Documentation, Nonconformance Reports, Inspection ctivities and Product Disposition. Coordinates the review and revision of procedures, specifications, and forms to maintain and improve the QMS. Quality Help Desk and customer complaint point of contact and problem resolution including Questionnaires, Certificates and Customer Surveys, etc. Perform Internal Audits in support of internal requirements, 21 CFR 820 and ISO 13485 compliance. ssists in representing in customer quality audits, supplier quality audits and regulatory inspections Performs investigations and analysis activities to support resolution of quality issues. Collaborates with organizational teams to support quality system implementation. Creation of new product master files satisfying customer and quality system requirements Ensures quality standards by following company & departmental policies & procedures including, but not limited to: Product performance & quality verification. Identifying, recording, and investigating problems related to product, process & quality systems. Evaluating processes for improvements and standardization. Initiating action to prevent non-conformance in products, process, and quality systems. Training on quality systems and applicable regulations as identified by supervisor and required by position. Tracking/trending aspects of the QMS. Other job duties as required. Requirements:
Minimum of bachelor's degree in science, Engineering, Bioengineering or related field. Prefer Chemistry or Biology degree programs. Preferred Education, Years and Area of Experience. Minimum 3 years' experience in Quality or Regulatory, preferably in a medical device, pharmaceutical or biotechnology environment/industry. Thorough knowledge and practical application of Quality Systems Regulations 21 CFR 820 and ISO 13485 bility to develop, update and train on SOPs. Working knowledge of ISO standards and Quality Management Systems (QMS). Problem solving techniques to perform investigations and drive root cause analysis. Related work experience performing internal/external audits. bility to monitor the QMS such as: Change Control, CAPA, Complaints, Nonconforming Materials and Products. Experience with Continuous Improvement, Lean or Six Sigma. Desired Experience / Qualifications / Skills: SAP, ETQ and/or PeopleSoft experience. Experience with statistical analysis. Project management experience. nimal by-product import/export regulations nimal health and/or virology, immunology, epidemiology knowledge bility to multi-task with ability to be organized. Strong interpersonal and communication skills. Strong time management skills and attention to detail. bility to influence others in a team environment while collaborating with peers and functional areas. bility to work independently with minimal supervision.