Quality Systems Analyst ensuring compliance with quality standards and regulatory requirements. Driving continuous improvement in a global biosciences company.
Responsibilities
Maintain and continuously improve the QMS to ensure ongoing compliance with internal standards and applicable regulatory requirements.
Facilitate the development and revision of Standard Operating Procedures (SOPs), work instructions, validation documents, and quality records.
Administer the electronic document control system, including change control, version management, and archival.
Coordinate and support internal, external, supplier, and regulatory audits.
Facilitate process and site quality reviews.
Lead root cause investigations and implement corrective and preventative actions (CAPA).
Monitor process and system performance using Statistics Process Control (SPC) and other quality metrics.
Provide training on quality systems, quality processes, systems, and continuous improvement tools.
Requirements
Bachelor’s degree or equivalent experience in a professional, technical, or scientific field
Quality Assurance or Science-Technology-Engineering-Mathematics (STEM), or a related field preferred
Certifications from American Society for Quality (e.g. CQA, EQE) and/or Lean Six Sigma (green belt) preferred
Knowledge of statistical process control (SPC), measurement systems analysis (MSA) and design of experiment (DOE) are strongly preferred
A good communicator that is efficient at forming relationships with various members of the business and customers
Live within driving distance of our US based sites, preferably Germantown, NY or Albany, NY
Can prioritize based on varying business needs and demands, sometimes quickly
Sales Manager overseeing a team of engineers to implement technical solutions for AT&T. Responsible for customer integration, project management, and ensuring successful technical sales.
Drive technical sales solutions at AT&T Global Public Sector, serving government clients. Lead project management, customer integration, and support on advanced sales solutions.
Systems Engineer responsible for designing, implementing, and maintaining complex systems in aerospace and defense industry. Collaborating with teams to ensure efficient operations and optimal system performance.
Trading System Engineer at Synechron enhancing high - performance trading systems for fixed income markets. Focusing on design, implementation, and optimization within a fast - paced environment.
Senior Distinguished Technologist leading architecture and solution design for AI/ML Networking Infrastructure. Engaging with enterprises globally to influence tech strategy and provide technical leadership.
Staff Systems Engineer, Product Owner in Stryker's Endoscopy division translating product vision into software requirements. Collaboration with Systems Engineering, UX, R&D, and Marketing in hybrid work setting.
Mid - Level Systems Engineer delivering advanced geospatial intelligence capabilities at Leidos. Collaborating on system design and integration within the Intelligence Production Solutions Division.
Part - time Systems Architect/SME at AMERICAN SYSTEMS, supporting multi - level security systems for the Exodus Transport Network. Requires deep expertise and active Top Secret clearance.
Architectural leadership for next - generation DRAM products at Micron. Define DRAM system architectures and collaborate across technology domains for high - performance memory solutions.
HBM System Engineer at Micron developing innovative memory solutions for customers. Leading technical validation and testing efforts to ensure successful product launches.