Katalyst CRO
Overview
Join to apply for the
Senior Quality Engineer
role at
Katalyst CRO Location: Fremont, CA Responsibilities
Proactively investigate, identify, and implement best-in-class Quality Engineering practices. Provide quality engineering expertise in supplier management, design control, manufacturing, software quality, and sterilization activities. Provide focused quality engineering support and assume responsibility for timely and effective coordination and/or execution of assigned development project activities. Act as an effective leader or team member in supporting quality disciplines, decisions, and practices. Work with product development teams to develop measurable goals for quality. Participate in the risk management process, ensuring hazards are mitigated in product and process quality plans in accordance with client procedures and external standards (e.g., EN 14971). Participate in Usability Engineering and planning documentation (e.g., EN 62366/ISO 62366). Contribute to software documentation according to IEC 62304, biocompatibility testing according to applicable regulations and standards (including ISO 10993), and EMC testing according to IEC standards. Interface with other project team members and support development for product and packaging designs. Apply sound, systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues. Ensure development and execution of streamlined business systems to identify and resolve quality issues. Guide engineers regarding regulatory and statutory requirements applicable to the client\'s products. Support new product introduction projects through development and execution of process validation and verification test plans, protocols, and reports. Plan and direct the creation of quality standards, quality control and quality assurance procedures, sampling plans, test methods, fixtures, and processes for finished devices manufactured. Ensure process compliance through the design and development of quality plans, procedures, work instructions, flowcharts, forms, templates, checklists and other product or process-related documentation for recording, evaluating, and reporting quality data. Perform DHF/DHR/DMR reviews for product release. Provide quality expertise post-market release to analyze returned products. Perform technical failure analysis based on the physics of failure. Mentor and guide junior engineers and other QA team members, fostering knowledge development in quality engineering practices. Assist the Quality Department on an as-needed basis. Requirements
Bachelor\'s degree (or equivalent experience) with 7+ years of related experience. Ability to manage priorities and workflow in a rapidly changing environment. Proven experience in design for reliability, manufacturability, and serviceability. Proven experience managing quality in supplier, design, manufacturing, and software engineering environments. Demonstrated knowledge of consumables, sterilization processes, and regulatory requirements. Understanding of Medical Device QMS requirements and regulatory requirements, including FDA CFR 21 820 and ISO 13485. Understanding of product development lifecycles, design change and document change control, process verification and validation methodologies, and production process control methodologies in a medical device environment. Experience with product design changes, process verification and validation, and production process controls methodologies in an FDA/ISO regulated environment. Excellent organizational, problem-solving, and analytical skills. Excellent verbal and written communication skills. Excellent interpersonal and communication skills with the ability to develop trust with internal and external customers. Proficient technical writing skills and computer skills, including Microsoft Office suite. Experience in supporting quality audits and FDA inspections. Knowledge of GMP and applicable Quality System Standards. Certified Quality Engineer. Certified ISO 13485 Lead Auditor. Experience with medical device hardware, electrical, and software development. Strong background in process validation, risk management, and quality assurance for sterile devices and disposables. Experience with sterile medical instrumentation and disposables in a regulatory environment. Strong knowledge of fundamental quality and statistical tools. Drives results and optimizes work processes. Must be able to travel as business necessitates (up to 10%). Seniority level
Mid-Senior level Employment type
Full-time Job function
Quality Assurance Industries
Biotechnology Civil Engineering
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Join to apply for the
Senior Quality Engineer
role at
Katalyst CRO Location: Fremont, CA Responsibilities
Proactively investigate, identify, and implement best-in-class Quality Engineering practices. Provide quality engineering expertise in supplier management, design control, manufacturing, software quality, and sterilization activities. Provide focused quality engineering support and assume responsibility for timely and effective coordination and/or execution of assigned development project activities. Act as an effective leader or team member in supporting quality disciplines, decisions, and practices. Work with product development teams to develop measurable goals for quality. Participate in the risk management process, ensuring hazards are mitigated in product and process quality plans in accordance with client procedures and external standards (e.g., EN 14971). Participate in Usability Engineering and planning documentation (e.g., EN 62366/ISO 62366). Contribute to software documentation according to IEC 62304, biocompatibility testing according to applicable regulations and standards (including ISO 10993), and EMC testing according to IEC standards. Interface with other project team members and support development for product and packaging designs. Apply sound, systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues. Ensure development and execution of streamlined business systems to identify and resolve quality issues. Guide engineers regarding regulatory and statutory requirements applicable to the client\'s products. Support new product introduction projects through development and execution of process validation and verification test plans, protocols, and reports. Plan and direct the creation of quality standards, quality control and quality assurance procedures, sampling plans, test methods, fixtures, and processes for finished devices manufactured. Ensure process compliance through the design and development of quality plans, procedures, work instructions, flowcharts, forms, templates, checklists and other product or process-related documentation for recording, evaluating, and reporting quality data. Perform DHF/DHR/DMR reviews for product release. Provide quality expertise post-market release to analyze returned products. Perform technical failure analysis based on the physics of failure. Mentor and guide junior engineers and other QA team members, fostering knowledge development in quality engineering practices. Assist the Quality Department on an as-needed basis. Requirements
Bachelor\'s degree (or equivalent experience) with 7+ years of related experience. Ability to manage priorities and workflow in a rapidly changing environment. Proven experience in design for reliability, manufacturability, and serviceability. Proven experience managing quality in supplier, design, manufacturing, and software engineering environments. Demonstrated knowledge of consumables, sterilization processes, and regulatory requirements. Understanding of Medical Device QMS requirements and regulatory requirements, including FDA CFR 21 820 and ISO 13485. Understanding of product development lifecycles, design change and document change control, process verification and validation methodologies, and production process control methodologies in a medical device environment. Experience with product design changes, process verification and validation, and production process controls methodologies in an FDA/ISO regulated environment. Excellent organizational, problem-solving, and analytical skills. Excellent verbal and written communication skills. Excellent interpersonal and communication skills with the ability to develop trust with internal and external customers. Proficient technical writing skills and computer skills, including Microsoft Office suite. Experience in supporting quality audits and FDA inspections. Knowledge of GMP and applicable Quality System Standards. Certified Quality Engineer. Certified ISO 13485 Lead Auditor. Experience with medical device hardware, electrical, and software development. Strong background in process validation, risk management, and quality assurance for sterile devices and disposables. Experience with sterile medical instrumentation and disposables in a regulatory environment. Strong knowledge of fundamental quality and statistical tools. Drives results and optimizes work processes. Must be able to travel as business necessitates (up to 10%). Seniority level
Mid-Senior level Employment type
Full-time Job function
Quality Assurance Industries
Biotechnology Civil Engineering
#J-18808-Ljbffr