Stark Pharma
Quality & Compliance Validation Engineer
Stark Pharma, California, Missouri, United States, 65018
Quality & Compliance Validation Engineer
Position:
Quality & Compliance Validation Engineer Location:
Los Gatos, CA (Local candidates only) Experience:
7+ years Duration:
12+ months contract Overview:
We're seeking an experienced Quality & Compliance Validation Engineer responsible for process validation and ensuring FDA/ISO compliance within a medical device manufacturing environment. The role focuses on maintaining audit readiness, driving process improvements, and executing validations that meet regulatory and quality standards. Qualifications
Bachelor's or Master's degree in Engineering 7+ years of experience in the medical device industry and product development Strong knowledge of FDA QSR and ISO 13485 quality systems Excellent documentation, communication, and problem-solving skills Detail-oriented, adaptable, and comfortable working in cleanroom environments Experience in startup or fast-paced manufacturing settings preferred Key Responsibilities
Stay current with FDA, ISO, and GHTF guidance requirements Develop and maintain validation documentation, including Master Plans, Protocols, Reports (IQ/OQ/PQ/PPQ), PFMEA, and Monitoring Plans Execute DOE and physical testing using equipment such as Instron, Mark-10, and Micro-Vu Perform process validation for manufacturing methods such as adhesive bonding, UV curing, pouch sealing, 3D printing, braiding, laminating, thermoforming, and laser cutting/welding Support supplier process validations (laser welding, injection molding, luer bonding, etc.) Conduct Attribute and Variable Test Method Validations Apply statistical tools for sampling, data analysis, and documentation Plan and manage projects using Gantt charts, task lists, and structured review meetings Lead problem-solving initiatives using A3 and Six Sigma DMAIC methodologies Provide support for related validation activities including Facility, Packaging, Sterilization, eQMS, and ERP/CRM systems
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Position:
Quality & Compliance Validation Engineer Location:
Los Gatos, CA (Local candidates only) Experience:
7+ years Duration:
12+ months contract Overview:
We're seeking an experienced Quality & Compliance Validation Engineer responsible for process validation and ensuring FDA/ISO compliance within a medical device manufacturing environment. The role focuses on maintaining audit readiness, driving process improvements, and executing validations that meet regulatory and quality standards. Qualifications
Bachelor's or Master's degree in Engineering 7+ years of experience in the medical device industry and product development Strong knowledge of FDA QSR and ISO 13485 quality systems Excellent documentation, communication, and problem-solving skills Detail-oriented, adaptable, and comfortable working in cleanroom environments Experience in startup or fast-paced manufacturing settings preferred Key Responsibilities
Stay current with FDA, ISO, and GHTF guidance requirements Develop and maintain validation documentation, including Master Plans, Protocols, Reports (IQ/OQ/PQ/PPQ), PFMEA, and Monitoring Plans Execute DOE and physical testing using equipment such as Instron, Mark-10, and Micro-Vu Perform process validation for manufacturing methods such as adhesive bonding, UV curing, pouch sealing, 3D printing, braiding, laminating, thermoforming, and laser cutting/welding Support supplier process validations (laser welding, injection molding, luer bonding, etc.) Conduct Attribute and Variable Test Method Validations Apply statistical tools for sampling, data analysis, and documentation Plan and manage projects using Gantt charts, task lists, and structured review meetings Lead problem-solving initiatives using A3 and Six Sigma DMAIC methodologies Provide support for related validation activities including Facility, Packaging, Sterilization, eQMS, and ERP/CRM systems
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