Responsibilities: Supports multiple continuous improvement initiatives and may lead or support Kaizen events.
Key contributor to the development and execution of streamlined business systems which effectively identify and resolve quality issues.
pply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
Evaluate the value and impact of both ongoing and completed quality improvement projects.
Establish and present quality performance metrics which drive accountability and delivery of targets.
Identify, propose and implement quality management procedures and processes to drive the interrogation of relevant data, trend analysis and to continuously improve the quality management and system assurance function.
Support the Quality Assurance review and approval of complex change controls, deviations/investigations, CAPAs, quality engineering, and continuous improvement to ensure that they meet the requirements of applicable standards and procedures and are clearly and appropriately justified.
Solve challenges related to customer complaints - Lead and drive the investigation, resolution and prevention of product and process nonconformance's.
Supports Implementation of procedures, training and systems and ensure product complaints process for all new products is in place to support their launch and lifecycle management.
Maintains and continuously improves highly effective procedures related to complaint processing and complaint investigation.
Requirements: Bachelor's degree in science, Engineering or a closely related discipline.
With Minimum 5 years of relevant working experience.
Six Sigma Black Belt (CSSBB) or ASQ Certified Quality Engineer (CQE) is highly desired, plus engineering experience and demonstrated use of Quality tools/methodologies.
Knowledge of FDA, GMP, ISO 13485, and ISO 14971.
Strong project management and leadership skills.
Medical Devices/Diagnostics and/or other regulated healthcare industry experience is required.
Experience implementing various product and process improvement methodologies (e.g., Value Stream Mapping, Six-Sigma (DMAIC), Lean, Kaizen).
Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
Strong organizational and follow-up skills, as well as attention to detail.
Demonstrates analytical capability to find systemic issues to root cause, and create actions plans to mitigate, close and/or eliminate.