JenaValve Technology, Inc.
Senior Engineer, Quality
JenaValve Technology, Inc., Irvine, California, United States, 92713
Overview
Job Title:
Senior Engineer, Quality Supervisor/Manager Title:
Global Director, Quality Assurance Job Description Summary:
Provide Quality Engineering support to various areas including design verification and validation, production line/receiving inspection support, process validation (IQ/OQ/PQ), process optimization, non-conformance investigation, risk management, and post-market assessment. Responsibilities
Partner with Manufacturing Engineers to develop and qualify manufacturing processes. Review and approve design changes. Provide technical Quality support to ensure new processes/procedures are in compliance with the governing standards and procedures. Provide technical Quality support during review of the standards. Review of documentation and production records to ensure all product is produced in a compliant manner and ensure all manufacturing records received are reviewed, approved, and filed in compliance with QSRs and ISO standards. Creation and approval of test protocols and reports in support of equipment qualifications (IQ/OQ/PQ), design verification, continuous improvement projects, validation activities and Gage R&R studies. Lead cross-functional teams in the creation and development of risk management documents, Process FMEA and others as required by JenaValve internal procedures. Lead cross-functional teams in the generation and implementation of improvement projects. Assist in the completion, generation and implementation of the Validation Master Plan and supporting activities. Audit the manufacturing line to ensure compliance to governing procedures is being met. Execute Internal and External (supplier) audits. Maintain applicable equipment, including preventative maintenance and calibration, in line with the relevant SOPs. Lead root cause analysis investigations for production related nonconformities and develop and aid in the implementation corrective actions. Take on other roles required to support continuous improvement within Quality and manufacturing. Serve as a mentor to more junior Quality Engineers on quality engineering-related activities. Qualifications
Bachelor of Science degree in engineering. 4 + years medical device Quality/Regulatory experience in a medical device, pharmaceutical or life sciences technology driven company. Experience with nonconformances, investigations, root cause analysis, risk analysis and corrective/preventive actions. Must be familiar with 21CFR820, ISO 13485, and ISO14971 requirements. Skills And Abilities Required For This Job
Can identify work priorities and deploy resources to ensure business needs are met. Must be able to work effectively and collaborate within cross-functional teams. Must be able to effectively articulate (verbally and in writing) results and conclusions to technical and non- technical personnel. Must have strong project management and documentation skills. Must take initiative and have the ability to conduct hands-on work. Must possess the ability to handle multiple tasks with high attention to detail. Seniority level
Mid-Senior level Employment type
Full-time Job function
Quality Assurance Industries
Medical Equipment Manufacturing
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Job Title:
Senior Engineer, Quality Supervisor/Manager Title:
Global Director, Quality Assurance Job Description Summary:
Provide Quality Engineering support to various areas including design verification and validation, production line/receiving inspection support, process validation (IQ/OQ/PQ), process optimization, non-conformance investigation, risk management, and post-market assessment. Responsibilities
Partner with Manufacturing Engineers to develop and qualify manufacturing processes. Review and approve design changes. Provide technical Quality support to ensure new processes/procedures are in compliance with the governing standards and procedures. Provide technical Quality support during review of the standards. Review of documentation and production records to ensure all product is produced in a compliant manner and ensure all manufacturing records received are reviewed, approved, and filed in compliance with QSRs and ISO standards. Creation and approval of test protocols and reports in support of equipment qualifications (IQ/OQ/PQ), design verification, continuous improvement projects, validation activities and Gage R&R studies. Lead cross-functional teams in the creation and development of risk management documents, Process FMEA and others as required by JenaValve internal procedures. Lead cross-functional teams in the generation and implementation of improvement projects. Assist in the completion, generation and implementation of the Validation Master Plan and supporting activities. Audit the manufacturing line to ensure compliance to governing procedures is being met. Execute Internal and External (supplier) audits. Maintain applicable equipment, including preventative maintenance and calibration, in line with the relevant SOPs. Lead root cause analysis investigations for production related nonconformities and develop and aid in the implementation corrective actions. Take on other roles required to support continuous improvement within Quality and manufacturing. Serve as a mentor to more junior Quality Engineers on quality engineering-related activities. Qualifications
Bachelor of Science degree in engineering. 4 + years medical device Quality/Regulatory experience in a medical device, pharmaceutical or life sciences technology driven company. Experience with nonconformances, investigations, root cause analysis, risk analysis and corrective/preventive actions. Must be familiar with 21CFR820, ISO 13485, and ISO14971 requirements. Skills And Abilities Required For This Job
Can identify work priorities and deploy resources to ensure business needs are met. Must be able to work effectively and collaborate within cross-functional teams. Must be able to effectively articulate (verbally and in writing) results and conclusions to technical and non- technical personnel. Must have strong project management and documentation skills. Must take initiative and have the ability to conduct hands-on work. Must possess the ability to handle multiple tasks with high attention to detail. Seniority level
Mid-Senior level Employment type
Full-time Job function
Quality Assurance Industries
Medical Equipment Manufacturing
#J-18808-Ljbffr