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ESR Healthcare
San Jose, CA, United States
Senior Mechanical Engineer san jose, ca ref We are seeking an exceptional Senior Mechanical Engineer to design, develop, and validate semi or fully automated equipment that is used for the scale-up of high volume, disposable devices. Your role is to find creative and sound engineering solutions to challenging problems with a strong focus on qualit
Job Source: ESR HealthcareESR Healthcare
San Jose, CA, United States
Senior Quality Assurance Engineer - Medical Device San Jose, CA ref Skills: Quality Assurance, Engineering, Medical Device, • Experience with FDA Quality System Regulations and ISO Standards (ISO 13485 and ISO 14971) is required, • Experience with non-conformances, CAPA, and Risk Management, • Experience in performing test method validation and Ga
Job Source: ESR HealthcareESR Healthcare
San Jose, CA, United States
Senior Imaging Engineer Python Matlab c/c++ San Jose, CA ref Skills: implementing ISP algorithm improvements, ISP technology, image quality metrics, tune ISP pipeline Job description Job insights Screening questions Candidate pipeline Experience level: Mid-senior Experience required: 5 Years Education level: Master’s degree Job function: Informat
Job Source: ESR HealthcareESR Healthcare
San Jose, CA, United States
Experience level: Mid-senior Experience required: 5 Years Education level: Bachelor’s degree Job function: Information Technology Industry: Information Technology and Services Compensation: View salary Total position: 1 Relocation assistance: Yes Visa : Only US citizens and Greencard holders JOB DETAILS You will be part of the ASIC Verification
Job Source: ESR HealthcareESR Healthcare
San Jose, CA, United States
Business development executive San Jose ca ref Experience level: Mid-senior Experience required: 2 Years Education level: Bachelor’s degree Job function: Sales Industry: Hospitality Compensation: $81,000 - $120,000 Total position: 1 Relocation assistance: No is seeking an Outside Business Development Executive to support our convenience solutions
Job Source: ESR HealthcareESR Healthcare
San Jose, CA, United States
engineering Project Manager SAN JOSE, CA REF We are seeking an experienced Project Manager to lead the successful execution and launch of engineering projects in a fast-paced environment. The position has responsibility for daily management of complex projects and requires a high degree of coordination with a cross-functional team including Engine
Job Source: ESR HealthcareESR Healthcare
San Jose, CA, United States
Research Scientist II San Jose, Ca REF RESEARCH SCIENTIST II San Jose, California, United States - Full-time REQUIREMENTS: Designs and undertakes high quality scientific experimentation resulting in formulation and process development of parenteral dosage forms Designs novel device component subassemblies for a novel device pill that support im
Job Source: ESR HealthcareESR Healthcare
San Jose, CA, United States
Director of Regulatory Affairs San Jose, CA REF DESCRIPTION The position is independently responsible for development of global regulatory strategy and representation of Regulatory Affairs on R&D project teams. You will be responsible for managing all Regulatory Affairs activities (nonclinical and clinical) for investigational drug-device combina
Job Source: ESR HealthcareSan Jose, CA, United States
Senior Quality Engineer - cGMP San Jose, CA REF
The Sr. Quality Assurance Engineer supports compliance with applicable regulatory requirements by maintaining an effective quality management system and implementing continuous improvements. This position is responsible for activities ranging from product development through commercialization. This is a hands-on role where the Sr. Quality Engineer will apply diversified knowledge of engineering, quality principles and practices for pharmaceutical and combination products. This position requires technical expertise in Aseptic Techniques. The Senior Quality Engineer is responsible for performing a quality role for the aseptic manufacturing, quality systems and compliance in accordance with cGMP, related company SOP’s, federal laws, guidelines, and regulations during the receipt, storage, manufacture, and distribution of products.
Requirements
Maintain and improve Quality System in accordance with FDA Regulations and ISO 13485 requirements
Provide hands-on direction for aseptic process and cGMP manufacturing activities
Support quality assurance activities, including, but not limited to: Risk Management (FMEAs, HA), internal and external audits, NCMRs and CAPAs
Collaborate with cross functional teams Manufacturing, Engineering, Facilities to ensure adherence to cGMP guidelines
Conduct investigations for issues associated with audits, lot history records and complaints. Approve manufacturing and testing deviations and investigations
Evaluation and support for implementation of new processes, lead continuous improvement of aseptic / sterile processes
Lead and support qualification and validation of cGMP equipment, facilities, utility systems, analytical test methods, cleaning and manufacturing processes. These duties will include, but are not limited to: the implementation and documentation of these validations and their lifecycle management in compliance with FDA and EU regulations
Manage the deviation system, perform QA assessment of deviations and ensure that all assessments are completed, review and approve deviation reports
Assist in the review and approval of lot history records and test records
Conduct audits at CMO, testing operations and internal audits
Assist in development, review and approval of process and equipment validation/qualifications (IQ, OQ, PQ), summary reports, ensure qualifications are conducted in accordance with the Validation Master Plan
Investigate product quality problems and determine root cause, gather and analyze data, and implement corrective actions to reduce or eliminate cause
Lead the resolution of quality issues related to non-conformance reports and CAPAs
Develop and initiate sampling procedures and statistical process control methods
Address systemic quality issues with suppliers or internal groups
Evaluate product changes for qualification and validation requirements and assist in change implementations
Other duties/ activities may be necessary to support departmental or company goals
Education and Job Experience
Bachelor’s degree or higher in Chemistry, Biology, or equivalent scientific discipline
A minimum of 7 years quality assurance/engineering experience within the pharmaceutical or biopharmaceutical industry is required
cGMP experience is required
Experience with performing utility qualification activities for vaporized hydrogen peroxide (VHP) system is preferred Excellent communication skills both oral and written
Understands and applies comprehensive knowledge of quality and GMP principles. Maintains current understanding of global GMP regulations
Experience with FDA Regulations (21 CFR part 820, part 210 and part 211) and ISO Standards (ISO 13485 and ISO 14971) is required
Experience regarding root cause analysis and statistical techniques (such as Cause and Effect Analysis, Fishbone Diagram, 5 Whys, Six Sigma processes)
Skills and Specifications
Ability to motivate and influence people
Must possess the ability to handle multiple tasks with high attention to detail Organizing, planning, and problem-solving skills
Good interpersonal and communication skills
Ability to work as a part of a team
Ability to review, analyze, summarize, and interpret data; draw conclusions and make appropriate recommendations and decisions; write reports
Ability to create and provide training
Good statistical and numerical ability
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Email Alert for Senior Quality Engineer - cGMP San Jose, CA REF jobs in San Jose, CA, United States
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