The Quality Assurance Engineer is responsible for providing manufacturing and/or engineering process support in accordance with documented procedures and practices. The Quality Assurance Engineer is responsible for the development, implementation, improvement, and continuous reinforcement of established Quality Assurance fundamental practices that are utilized in the local business.
· Responsible for ensuring 100 percent quality and regulatory compliance in accordance with documented procedures for all aspects of functional responsibility. Responsible for the development, implementation, and continuous improvement of process effectiveness and efficiency at the site.
· Develops process improvement plans using a variety of Quality and Continuous Process Improvement tools, including but not limited to Six Sigma, Lean Manufacturing, 5S, SPC, engineering studies, DOE, Gauge R&R, etc.
· Ensures process efficiency and compliance effectiveness through the development and implementation of process verification and validation plans, including Master Validation Plans (Site Level), Validation Master Plans (Product or Process specific plans), and the development of simple yet detailed process flow diagrams that describe critical process interdependencies with respect to process inputs, outputs, risks and impacts.
· Supports continuous product and process improvement through detailed failure analysis for non-conformances, and investigates, develops and implements effective and compliant solutions for product or process corrections, retrospective and remediation action plans, and for corrective and preventive actions (CAPA Program).
· Develops risk management tools and aids for use by the organization in accordance with documented procedures, including but not limited to PFMEA, DFMEA, Fault Tree Analysis, Failure Mode Analysis, etc. Supports design mitigation efforts. Develops process mitigation plans and strategies that are designed to mitigate the risks identified through the Risk Management process.
· Ensures process compliance through the development of simple yet comprehensive procedures, work instructions, flowcharts, forms, templates, checklists, worksheets, and other product and process related documentation.
· Performs a broad variety of tasks in support of product and process design as assigned by the departmental manager.
· Bachelor’s degree.
· 1 - 2 years of experience in manufacturing, engineering.
· Quality assurance experience.
· 2 years’ experience working with Quality System requirements (ie: ISO 13485, FDA, ANVISA, etc Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies & in-depth understanding of site level products & related processes.
· Demonstrated expertise to effectively communicate within all levels of the organization around concepts of design controls, design verification and validation activities; production &process controls; Corrective & Preventive Action (CAPA), complaints & risk management; & product quality improvement using tools such as six sigma, DFR, etc.
· Demonstrated collaboration, negotiation & conflict resolution skills.
· Excellent oral communication & report, business correspondence & procedure-writing skills.
· Demonstrated ability to lead, acknowledge, develop, communicate & implement a strategy under crisis situations to ensure compliance.
· Change agent with energy, passion & enthusiasm to drive change.
· Exceptional analytical, problem solving & root-cause analysis skills.
· Ability to multi-task & handle tasks with competing priorities effectively.
· Integrity: Accepting & adhering to high ethical, moral & personal values in decisions, communications, actions & when dealing with others.
· Demonstrated understanding of product development lifecycles, design change and document change control, process verification and validation methodologies, manufacturing / production process control methodologies, and servicing in a medical device environment.
· Demonstrated experience using word processing, spreadsheet, and presentation software.
· Ability to communicate using English (or local language).
· Demonstrated understanding of continuous quality / process improvement tools:
(As defined by the local site, e.g. DMIAC, SPC, Lean SS, 5S,).
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