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Senior Quality Engineer

Corona, California

Post Date: 04/20/2017 Job ID: 8404 Category: Technology

Job Description:
  • Coordinate Executive Management Review and quality scorecards
  • Creates an environment that fosters collaborative team work within and across functions
  • Doesn’ t give up before completing a task, even when dealing with setbacks.
  • Drives data analysis of quality performance to identify high priority issues relating to safety, complaints and systemic customer satisfaction.
  • Has the functional/technical knowledge and skills to perform a role at a consistently high level, even during periods of change and ambiguity
  • Lead the Quality Improvement Program for our Client including identifying state-of-the-art quality standards and practices; quality system planning and implementation; and influencing strategic planning
  • Lead the review of quality process issues and determine the best solution approach using a combination of people training, transformation, process updates, service improvements or technology changes
  • Provide leadership to monitoring and analyzing key elements of quality performance to identify product and process quality trends, quality system integrity and compliance with internal, as well as external standards and guidelines and intervene when necessary to implement solutions and drive continuous improvement
  • Provide oversight to the development of queries and reports from various data sources and data warehouse activities
  • Provide training and support to department staff and business users on the use of metrics
  • Provides the team with timely information that allows them to perform its work, as well as understand how its work fits into our Client’ s goals and objectives
  • Provides training to ensure proper implementation and use of quality tools and procedures as required.
  • Recognizes good talent internally and externally
  • Recommend goals and objectives for quality performance as part of annual and long range business plans
  • Support the escalation process when compliance issues cannot be resolved at the local level
  • Other duties may be assigned

 

Qualifications:
  • B.S. in Engineering or Science accompanied with 5+years of QA/RA experience and/or B.S. in a non-technical field accompanied with 7+ years of QA/RA experience
  • Ability to define problems, collect data, establish facts, and draw valid conclusions via statistical analysis
  • Ability to understand and apply mathematical concepts especially as they relate to statistics and trending
  • Ability to work several projects concurrently under tight deadlines and be able to prioritize to meet organizational goals, with attention to regulatory requirements
  • CQA, CQE or RAC desired
  • Experience in a medical device or other FDA regulated industry required- Experience in a medical device company / industry required
  • Experience in New Product Development/Design Controls required
  • Experience with the creation and ability to influence business processes using KPIs and metrics is required

 

 

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