Quality Engineer - Katalyst Healthcares & Life Sciences
Alameda, CA 94501
About the Job
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.
- Apply 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.
- 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.
Source : Katalyst Healthcares & Life Sciences
