Auditing, CAPAs, DFMEA, Validation, and more. Quality Systems & Compliance Develop and maintain quality systems and programs...This is a Quality Engineering position that focuses both on QA/QC but also product design. This role will help oversee...
and dynamic individual is needed to be an integral part of our post launch quality team, ensuring that we are continuously..., Quality, Manufacturing and Senior Executives, offering you exposure and interaction rarely found in other roles in the...
in a pharmaceutical quality control environment. Key Responsibilities: Develop, review, and execute Installation Qualification (IQ..., Engineering, Validation) to ensure timely and appropriate qualification. Prepare and maintain User Requirement Specifications...
, and test documentation to ensure quality requirements are fulfilled. · Review specifications, operation instructions, sheets..., process procedures, test procedures, inspection and test analysis. · Provide leadership in and employ advanced quality...
), operational qualification (OQ), performance qualification (PQ), and validation protocols. Provide quality presence..., implement, and maintain site-specific quality procedures (SOPs, work instructions, forms) governing validation, change control...
that cover data quality, transformation logic, aggregation rules, and business logic validation in addition to functional... and insights. You will apply Agile and Software Development Lifecycle (SDLC) QA (Quality Assurance) methodologies to validate...
proactive Quality Engineering responsibilities and support product development and manufacturing actions for all purchased... components, systems, and whole goods that contribute to successful product launches and support production quality requirements...
About This Role: Develops, establishes, and maintains software quality assurance methodologies, systems, and practices... that meet BSC, customer, and regulatory requirements. Serves as a Quality representative to improve awareness, visibility...
Roles & Responsibilities: Ensure quality engineering activities for released products comply with regulatory... and Validation (V&V) plans, protocols, and reports, Test Method Validation, as well as process validation activities (PFMEA, IQ, OQ...
NiFi, Talend, or Informatica. Understanding of data profiling, data quality, and data validation techniques...
validation activities, and driving overall operational excellence across R&D, Quality, and Regulatory functions..., or related regulated industry. Broad understanding of quality systems, validation, and documentation processes (not necessarily...
Position Summary Provides technical quality support and leadership to internal customers and external suppliers... to resolve and improve quality performance. Executes quality initiatives for manufactured products and drives quality system...
of the Edgewood Quality team and will support assigned product areas and also support the overall quality system by leading... quality related issues. Deploy through all stages of the supply chain Corrective and Preventive action management with root...
Validation. Partner with cross-functional teams in R&D, Manufacturing, and Quality. Ensure compliance with FDA, EUMDR, and QMS...&D, Manufacturing, or Quality Engineering (Medical Devices experience required). Strong expertise in Test Method Validation, Risk...
. Strong knowledge of FDA QSR, ISO 13485, ISO 14971, and EU MDR. Expertise in process validation, statistical analysis, and quality... more at Responsibilities: Lead initiatives to maintain and improve the Quality Management System (QMS) in compliance with FDA Quality Systems...
Roles & Responsibilities: 5 to 6 years of medical device Supplier Quality experience. Experience in Interacting..., Component qualification for components received from suppliers. Experience in Process Validation - IQ, OQ, PQ. Experience...
and debug tools for enhanced product validation. Bachelors degree with 10+ years of proven experience in Electrical Engineering...
SQL Server / Oracle (for data validation) PowerBuilder or File Builder understanding Experience testing XML, templates...
.qtspackaging.com and www.cretexmedical.com. Responsibilities: Quality Manager Ideal Candidate Profile QTS is currently seeking... an experienced, energetic, responsive, and well-organized full time Quality Manager. This position will be responsible for building...
Quality Technician/Engineer Job Description: We are seeking a Quality Technician/Engineer to support the process... development of tissue processing and implement quality inspections. The ideal candidate has hands-on experience with structural...