Katalyst CRO
Senior Quality Engineer
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Senior Quality Engineer
role at
Katalyst CRO Location: Fremont, CA Office. Responsibilities
The Senior Quality Engineer is responsible for the quality, safety, and reliability of the client's products. This role requires expertise in supplier, design, manufacturing, and software quality engineering. The engineer must demonstrate an understanding of consumables and sterilization processes. Lead efforts to develop, maintain, and continuously improve standard practices while proactively providing cross-functional support. Act as the Quality representative on current and/or new product development, taking initiative to influence, coach, and mentor teams appropriately. Support products throughout all development phases, test protocol development, process qualification/validation activities, the creation of statistically sound sampling plans, product investigations, and other quality processes. Support new product introduction projects through the development and execution of process validation and verification test plans, protocols, and reports. Mentor and guide junior engineers and other QA team members, fostering knowledge development in quality engineering practices. Support the Quality Department on an as-needed basis. Interface with other project team members and support the development effort for both product and packaging designs. 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; 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 (FDA 21 CFR 820 and ISO 13485). Experience with product development lifecycles, design/document change control, process verification and validation, and production process controls in a medical device environment. Excellent organizational, problem-solving, analytical, verbal and written communication skills; ability to develop trust with internal and external customers. Proficient in technical writing, Microsoft Office tools, and documentation programs. Experience supporting quality audits and FDA inspections; knowledge of GMP and applicable Quality System Standards. Certifications: Certified Quality Engineer and ISO 13485 Lead Auditor (preferred). Experience with medical device hardware, electrical, and software development; strong background in process validation, risk management, and quality assurance for sterile devices and disposables. Willingness and ability to travel up to 10% as needed. Seniority level
Mid-Senior level Employment type
Contract Job function
Quality Assurance Industries
Pharmaceutical Manufacturing
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Join to apply for the
Senior Quality Engineer
role at
Katalyst CRO Location: Fremont, CA Office. Responsibilities
The Senior Quality Engineer is responsible for the quality, safety, and reliability of the client's products. This role requires expertise in supplier, design, manufacturing, and software quality engineering. The engineer must demonstrate an understanding of consumables and sterilization processes. Lead efforts to develop, maintain, and continuously improve standard practices while proactively providing cross-functional support. Act as the Quality representative on current and/or new product development, taking initiative to influence, coach, and mentor teams appropriately. Support products throughout all development phases, test protocol development, process qualification/validation activities, the creation of statistically sound sampling plans, product investigations, and other quality processes. Support new product introduction projects through the development and execution of process validation and verification test plans, protocols, and reports. Mentor and guide junior engineers and other QA team members, fostering knowledge development in quality engineering practices. Support the Quality Department on an as-needed basis. Interface with other project team members and support the development effort for both product and packaging designs. 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; 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 (FDA 21 CFR 820 and ISO 13485). Experience with product development lifecycles, design/document change control, process verification and validation, and production process controls in a medical device environment. Excellent organizational, problem-solving, analytical, verbal and written communication skills; ability to develop trust with internal and external customers. Proficient in technical writing, Microsoft Office tools, and documentation programs. Experience supporting quality audits and FDA inspections; knowledge of GMP and applicable Quality System Standards. Certifications: Certified Quality Engineer and ISO 13485 Lead Auditor (preferred). Experience with medical device hardware, electrical, and software development; strong background in process validation, risk management, and quality assurance for sterile devices and disposables. Willingness and ability to travel up to 10% as needed. Seniority level
Mid-Senior level Employment type
Contract Job function
Quality Assurance Industries
Pharmaceutical Manufacturing
#J-18808-Ljbffr