ICONMA LLC Quality Engineer in PLANO, Texas
Duration: 14-15 MonthsDescription:The purpose of this position is to initiate medical device quality assurance activities. These activities must be in accordance with FDA Quality System Regulation, ISO13485 and other international standards. This position will also support device complaint investigation and failure analysis as required. Essential Duties and Responsibilities: Develop incoming inspection processes and document incoming inspection activities. Provide in-process QA support to include inspection and document review. Complete final acceptance activities. Manage the sterilization process, including validations and product sterile loads. Track nonconforming material and lead Material Review Board (MRB) efforts. Interface and take lead QA role in interactions with suppliers, contractors and consultants that supply components, subassemblies and contract processing. Lead complaint investigations on returned product. Manage corrective action and quality improvement activities. Manage aspects of internal quality system relating to receiving inspection, calibration, MRB, etc. Assist in the performance of quality system internal auditing. Support quarterly management review meetings. Establish, monitor and evaluate quality system metrics.General Qualifications- Bachelor level degree in Engineering, Technical Field, or equivalent (advanced degree preferred) - 8+ years technical experience- Previous Quality assurance/engineering experience and demonstrated use of Quality tools/methodologies (CAPA, NCMRs, Root Cause Analysis, Process Validations, Continuous Improvement)- Detailed knowledge of FDA, GMP, and ISO 13485- Solid communication and interpersonal skills- Demonstrated and impactful project management and leadership skills, including the ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner- Advanced computer skills, including statistical/data analysis and report writing skills- Prior medical device experience- ASQ CQT, CQE, CQA certification preferred- Six Sigma root cause analysis/problem solving training and experience preferred.- 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 communications with ability to effectively communicate at multiple levels in the organization.- Multitasks, prioritizes and meets deadlines in timely manner.