A Medical Device client in Alameda, CA is currently looking for a to work on a Sr. Product Quality Engineer 12-24 months contract with the possibility of extension/Direct hire. The selected person will be working an 8 am- 5 pm Monday to Friday work schedule.
Summary
Supports multiple Quality process improvement initiatives and provides Lean Six Sigma Project support for high-impact business improvements. Responsible for quality-related activities to deliver consistently; high-quality documents; services; products and processes.
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 that drive accountability and delivery of targets
Identify, propose and implement quality management procedures and processes to drive the interrogation of relevant data, and 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
Supports Implementation of procedures, training, and systems and ensures 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
Qualifications
Bachelor’s degree in Science, Engineering or a closely related discipline. With Minimum 4 years of relevant working experience
Six Sigma Black Belt (CSSBB) or ASQ Certified Quality Engineer (CQE) is highly desired
Engineering experience and demonstrated use of Quality tools/methodologies
Knowledge of FDA, GMP, ISO 13485, and ISO 14971.
Solid communication and interpersonal skills
Strong project management and leadership skills
Advanced computer skills, including statistical/data analysis and report writing skills is a plus
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)
Experience working in a broader enterprise/cross-division business unit model
preferred.
Ability to work in a highly matrixed and geographically diverse business environment.
Ability to work within a team and as an individual contributor in a fast-paced, changing
environment.
Ability to leverage and/or engage others to accomplish projects.
Strong verbal and written communication with ability to effectively communicate at
multiple levels in the organization.
Multitasks prioritizes and meets deadlines in a timely manner.
Strong organizational and follow-up skills, as well as attention to detail.
Demonstrates analytical capability to find systemic issues to root cause, and create action plans to mitigate, close and/or eliminate.
Knowledge of software and hardware development life cycle