Katalyst CRO
Quality Assurance Engineer
Katalyst CRO - Irvine, California, United States, 92713
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Overview
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Quality Assurance Engineer
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Quality Assurance Engineer
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Katalyst CRO This position has primary responsibility for the investigation, review, and completion of all Quality Engineering complaint issue analysis tasks utilizing various quality system inputs. Review individual complaints and associated service data to determine risk level and complete investigation into the "as "determined problem code and cause codes for each complaint. Analyze data from various quality inputs (including but not limited to: Field Corrective Action (FCA), Complaints, FDA Medical Device Reports (MDR), etc.) to determining trends and systemic issues. Prepare and issue reports based on information analysis. Review existing investigation reports and identify gaps for GMP compliance. Develop strategies and plans to close the gaps in an efficient and technical manner. Develop and communicate expectations for quality performance, continuous improvement and process controls for marketed products. Monitor and drive corrective action and continuous improvement activities that directly impact performance measures by performing primary investigations, conducting data analysis, and implementing corrective actions. Conduct or lead corrective and preventive actions in manufacturing using formal problem-solving tools and documentation. Support CAPA and maintenance activities for existing product lines. Recommend and/or support projects for improvements to the quality system as approved by management.
Responsibilities
This position has primary responsibility for the investigation, review, and completion of all Quality Engineering complaint issue analysis tasks utilizing various quality system inputs. Review individual complaints and associated service data to determine risk level and complete investigation into the "as "determined problem code and cause codes for each complaint. Analyze data from various quality inputs (including but not limited to: Field Corrective Action (FCA), Complaints, FDA Medical Device Reports (MDR), etc.) to determining trends and systemic issues. Prepare and issue reports based on information analysis. Review existing investigation reports and identify gaps for GMP compliance. Develop strategies and plans to close the gaps in an efficient and technical manner. Develop and communicate expectations for quality performance, continuous improvement and process controls for marketed products. Monitor and drive corrective action and continuous improvement activities that directly impact performance measures by performing primary investigations, conducting data analysis, and implementing corrective actions. Conduct or lead corrective and preventive actions in manufacturing using formal problem-solving tools and documentation. Support CAPA and maintenance activities for existing product lines. Recommend and/or support projects for improvements to the quality system as approved by management.
Requirements:
A Bachelor of Science degree in Engineering. 1-3 years of Medical Device experience. Medical Device Experience with knowledge of 21CFR820 preferred. Investigational research skills. Experience with any statistical software packages (Minitab a plus). Desired experience in the medical device industry in the development and deployment of Quality Systems, and process controls, and continuous improvement methods. Knowledge and working application of FDA cGMP; ANSI/ISO/ASQC requirements; CMDAS (optional). Knowledge and working application of reading and understanding blueprints and technical drawings. Demonstrated strong analytical problem solving (Root Cause Investigations. Display a solid technical understanding of engineering principles and procedures (e.g., CAD and its application or scheduling a series of technical tasks utilizing software-based tools). Computer competency in Word, Excel, Power Point, Minitab, Access and databases. Ability to multi-task and methodically manage projects. Seniority level
Seniority level
Associate Employment type
Employment type
Contract Job function
Job function
Quality Assurance Industries
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Quality Assurance Engineer
role at
Katalyst CRO Join to apply for the
Quality Assurance Engineer
role at
Katalyst CRO This position has primary responsibility for the investigation, review, and completion of all Quality Engineering complaint issue analysis tasks utilizing various quality system inputs. Review individual complaints and associated service data to determine risk level and complete investigation into the "as "determined problem code and cause codes for each complaint. Analyze data from various quality inputs (including but not limited to: Field Corrective Action (FCA), Complaints, FDA Medical Device Reports (MDR), etc.) to determining trends and systemic issues. Prepare and issue reports based on information analysis. Review existing investigation reports and identify gaps for GMP compliance. Develop strategies and plans to close the gaps in an efficient and technical manner. Develop and communicate expectations for quality performance, continuous improvement and process controls for marketed products. Monitor and drive corrective action and continuous improvement activities that directly impact performance measures by performing primary investigations, conducting data analysis, and implementing corrective actions. Conduct or lead corrective and preventive actions in manufacturing using formal problem-solving tools and documentation. Support CAPA and maintenance activities for existing product lines. Recommend and/or support projects for improvements to the quality system as approved by management.
Responsibilities
This position has primary responsibility for the investigation, review, and completion of all Quality Engineering complaint issue analysis tasks utilizing various quality system inputs. Review individual complaints and associated service data to determine risk level and complete investigation into the "as "determined problem code and cause codes for each complaint. Analyze data from various quality inputs (including but not limited to: Field Corrective Action (FCA), Complaints, FDA Medical Device Reports (MDR), etc.) to determining trends and systemic issues. Prepare and issue reports based on information analysis. Review existing investigation reports and identify gaps for GMP compliance. Develop strategies and plans to close the gaps in an efficient and technical manner. Develop and communicate expectations for quality performance, continuous improvement and process controls for marketed products. Monitor and drive corrective action and continuous improvement activities that directly impact performance measures by performing primary investigations, conducting data analysis, and implementing corrective actions. Conduct or lead corrective and preventive actions in manufacturing using formal problem-solving tools and documentation. Support CAPA and maintenance activities for existing product lines. Recommend and/or support projects for improvements to the quality system as approved by management.
Requirements:
A Bachelor of Science degree in Engineering. 1-3 years of Medical Device experience. Medical Device Experience with knowledge of 21CFR820 preferred. Investigational research skills. Experience with any statistical software packages (Minitab a plus). Desired experience in the medical device industry in the development and deployment of Quality Systems, and process controls, and continuous improvement methods. Knowledge and working application of FDA cGMP; ANSI/ISO/ASQC requirements; CMDAS (optional). Knowledge and working application of reading and understanding blueprints and technical drawings. Demonstrated strong analytical problem solving (Root Cause Investigations. Display a solid technical understanding of engineering principles and procedures (e.g., CAD and its application or scheduling a series of technical tasks utilizing software-based tools). Computer competency in Word, Excel, Power Point, Minitab, Access and databases. Ability to multi-task and methodically manage projects. Seniority level
Seniority level
Associate Employment type
Employment type
Contract Job function
Job function
Quality Assurance Industries
Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO by 2x Get notified about new Quality Assurance Engineer jobs in
Irvine, CA . Quality Assurance/Supplier Quality Engineering/Quality Control (QA/SQE/QC) Engineer
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Irvine, CA $105,000.00-$185,000.00 10 hours ago Irvine, CA $110,000.00-$130,000.00 4 days ago Irvine, CA $150,000.00-$200,000.00 1 day ago Rancho Santa Margarita, CA $100,000.00-$120,000.00 3 weeks ago Irvine, CA $100,000.00-$120,000.00 2 days ago Irvine, CA $100,000.00-$150,000.00 2 days ago Quality Assurance & Quality Control Engineer II
Rancho Santa Margarita, CA $115,000.00-$125,000.00 3 weeks ago Software Quality Assurance Engineer (QA / QC) In-Person in Aliso Viejo
Software Development Engineer in Test 2025 (US)
Irvine, CA $105,000.00-$185,000.00 1 week ago 3.94 Software Quality Assurance Engineer
Irvine, CA $100,000.00-$120,000.00 3 months ago Irvine, CA $100,000.00-$150,000.00 3 months ago Irvine, CA $100,000.00-$120,000.00 3 months ago Software Engineer II/ Quality Automation
Santa Ana, CA $110,000.00-$130,000.00 6 days ago Sr. Quality Assurance Software Engineer (ISO 13485)
Irvine, CA $95,833.00-$130,000.00 3 days ago Irvine, CA $125,000.00-$169,800.00 1 week ago Tustin, CA $85,600.00-$113,420.00 1 day ago Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr