Senior Quality Specialist

Job Description

Senior quality specialists use the tests that quality engineers designed to inspect products and all aspects of production and manufacturing. They might also work to make sure manufacturing equipment is up to date, train employees on quality policies and create standard operating procedures for the company and its staff. Creates, implements, and maintains quality plans and gap assessments for corrective actions and process improvements projects. Authors, reviews, and approves standard operating procedures, job aids, training and other QMS process related documents. Coordinates activities and/or collaborates with cross-functional international colleagues on assigned projects Prepare, analyze, and present metrics and quality management review data to drive action and business value. Provides quality expertise, training, and support to project teams. Participates in the design, development, and testing of QMS software applications, specifically Agile. Provides timely updates and follows up on open issues of all assigned activities.QualificationsBachelors or masters degree in biology, chemistry, biotechnology, engineering, or a related field 8+ years of related experience in a medical device industry Experience in medical device or in-vitro diagnostic quality (ISO 13485, MDSAP, CFR820, IVDR) is required Excellent project management, including planning, team management, stakeholder management, and reporting. Excellent oral and written communication skills. Able to summarize and communicate complex information in a precise and effective way. Excellent analytical and problem-solving skills. Able to find the right solutions in compliance with the regulations Experience with common quality tools (fishbone diagram, control charts, pareto, histograms, scatter plots) Experience with Agile is a plus Experience leading Lean / Six Sigma / DMAIC projects is a plus Team player with ability to influence and drive change Able to manage multiple priorities and work efficiently with minimal supervision

Keyskills :
verbal communicationtime managementquality standardsattention to detailproblem-solving