Aditi Consulting
Quality Assurance Senior Specialist
Aditi Consulting, Thousand Oaks, California, United States, 91362
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This range is provided by Aditi Consulting. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range
$32.00/hr - $36.00/hr Summary
Be part of the Digital Quality Management System, a transformation that will encompass the process of redesigning, simplification, and sustainment within a new technology ecosystem of advanced analytics and system integrations. When completed, the Digital Quality Management System will be a cornerstone for the Quality End-to-End Transformation delivering a streamline and modernized Quality Management System to handle the increases in product volume and complexity across the enterprise (R&D, Operations, and GCO). In this vital role you will support the quality management system team to provide proactive compliance oversight to processes, functional areas and partner groups within the Corporate Quality Management System organization. Under general supervision, provide tactical support activities to Quality Management System Lead. Responsibilities
Manage collaboration on the process improvement, transfer and sustainment of QMS processes, across Operations and R&D to the Digital QMS platform for health and control processes. Leads Digital QMS audit & inspection readiness, deviations and change control activities. Manage Organizational Change Management (OCM) activities and Training deliverables that support the Digital QMS; maintain knowledge of current systems, tools, standard methodologies, and terminology and ensure adherence to GxP (GMP, GDP, GCP, GLP & GPvP) and other applicable regulations. Manages and provides oversight of documents / records within the Quality Management System. Oversight of process key performance indicators and metrics. Manage external contractors providing services to Digital QMS. Working across teams managing priorities. Preferred Qualifications
Strong knowledge and experience in Medical Device Quality System Regulations and Medical Device Standards. Previous experience managing implementation of Quality Management System Requirements, Product Standards / Regulatory Requirements (e.g. FDA CFRs for Biologics and Medical Devices, FDA Combination Product Regulation, ISO:13845, EU Medical Device Directive, EN 60601and IEC/EN 62304). Experience supporting pre-clinical, clinical research, and/or pharmacovigilance activities; ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Experience with risk-based Supplier Quality Management process. Management of Global Inspection and Audit programs. Proficient working on multiple projects in a deadline driven environment. Strong decision making and organization skills with the ability to prioritize multiple business priorities. Experience in project management, process improvement and quality system management. Effective verbal and written communication skills (writing and presentations) in English. Pay Transparency
The typical base pay for this role across the U.S. is $32.00 - $36.00/hour. Non‑exempt positions are eligible for overtime at a rate of 1.5 times the base hourly rate for all hours worked in excess of 40 in a work week, or as required by state or local law. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience. Full‑time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, health savings accounts with qualified medical plan enrollment, 10 paid days off, 3 days paid bereavement leave, 401(k) plan participation with employer match, life and disability insurance, commuter benefits, dependent care flexible spending account, accident insurance, critical illness insurance, hospital indemnity insurance, accommodations and reimbursement for work travel, and discretionary performance or recognition bonus. Sick leave and mobile phone reimbursement provided based on state or local law. Seniority level
Entry level Employment type
Contract Job function
Quality Assurance
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$32.00/hr - $36.00/hr Summary
Be part of the Digital Quality Management System, a transformation that will encompass the process of redesigning, simplification, and sustainment within a new technology ecosystem of advanced analytics and system integrations. When completed, the Digital Quality Management System will be a cornerstone for the Quality End-to-End Transformation delivering a streamline and modernized Quality Management System to handle the increases in product volume and complexity across the enterprise (R&D, Operations, and GCO). In this vital role you will support the quality management system team to provide proactive compliance oversight to processes, functional areas and partner groups within the Corporate Quality Management System organization. Under general supervision, provide tactical support activities to Quality Management System Lead. Responsibilities
Manage collaboration on the process improvement, transfer and sustainment of QMS processes, across Operations and R&D to the Digital QMS platform for health and control processes. Leads Digital QMS audit & inspection readiness, deviations and change control activities. Manage Organizational Change Management (OCM) activities and Training deliverables that support the Digital QMS; maintain knowledge of current systems, tools, standard methodologies, and terminology and ensure adherence to GxP (GMP, GDP, GCP, GLP & GPvP) and other applicable regulations. Manages and provides oversight of documents / records within the Quality Management System. Oversight of process key performance indicators and metrics. Manage external contractors providing services to Digital QMS. Working across teams managing priorities. Preferred Qualifications
Strong knowledge and experience in Medical Device Quality System Regulations and Medical Device Standards. Previous experience managing implementation of Quality Management System Requirements, Product Standards / Regulatory Requirements (e.g. FDA CFRs for Biologics and Medical Devices, FDA Combination Product Regulation, ISO:13845, EU Medical Device Directive, EN 60601and IEC/EN 62304). Experience supporting pre-clinical, clinical research, and/or pharmacovigilance activities; ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Experience with risk-based Supplier Quality Management process. Management of Global Inspection and Audit programs. Proficient working on multiple projects in a deadline driven environment. Strong decision making and organization skills with the ability to prioritize multiple business priorities. Experience in project management, process improvement and quality system management. Effective verbal and written communication skills (writing and presentations) in English. Pay Transparency
The typical base pay for this role across the U.S. is $32.00 - $36.00/hour. Non‑exempt positions are eligible for overtime at a rate of 1.5 times the base hourly rate for all hours worked in excess of 40 in a work week, or as required by state or local law. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience. Full‑time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, health savings accounts with qualified medical plan enrollment, 10 paid days off, 3 days paid bereavement leave, 401(k) plan participation with employer match, life and disability insurance, commuter benefits, dependent care flexible spending account, accident insurance, critical illness insurance, hospital indemnity insurance, accommodations and reimbursement for work travel, and discretionary performance or recognition bonus. Sick leave and mobile phone reimbursement provided based on state or local law. Seniority level
Entry level Employment type
Contract Job function
Quality Assurance
#J-18808-Ljbffr