Title: Quality Engineer
Location: United States-Florida-Clearwater Site
Summary:
The role of Quality Engineer Insertion Devices is integral to the on-going compliance of the inserter manufacturing processes. The Quality Engineer is involved in all stages of the product life cycle including:
· New Product Support:Works with project teams to ensure the product is transferred into manufacturing right the first time and validations are conducted in accordance with requirements.
· Manufacturing support: Leads efforts in conjunction with manufacturing and engineering to develop plans for continual improvement of product and process quality. Ensures that decisions are made based on sound Quality principles and regulatory guidelines. Supports/leads investigations and corrective action efforts. Promotes use of statistical analysis for determination of improvements, and provides analyses to support risk mitigation.
· Post-launch maintenance: Evaluates complaint trends and drives improvements. Investigates individual complaints as needed.
Manufacturing Support
· Supports manufacturing in improvement of processes, resolution of issues, maintenance/ improvement of quality system.
· Uses Lean/six sigma tools to identify areas of improvement, specifically related to process controls.
· Guides engineering/manufacturing personnel in establishment of appropriate qualification, validation criteria.
· Evaluate proposed changes for design control requirements.
· Independently leads failure investigations, using root cause analysis tools, and proposing/implementing systemic corrective actions. Identifies areas of systemic weakness, and leads initiatives to implement corrective action.
Analyzes data
· Uses relevant statistical tools to analyze data for proactive improvements.
· Uses relevant statistical tools for leading problem solving activities.
· Provides routine analysis of performance indicators. Presents this information to management, supervisors, and manufacturing operators. Leads initiatives to improve performance.
Core team member for new product development
· Key participant in the design transfer process. Guides project team in development of validations of the manufacturing process and quality plans for the integration into manufacturing.
· Evaluates current Quality System, and determines how new products will fit within system. Determines if any changes are required.
· Leads teams to develop PFMEA for new processes and process changes. Focus team on implementing capable processes, process controls, and error-proofing measures.
· Develops/updates Risk Management files.
· Support development of verification and validation strategies. Guides team on proper components of IQ/OQ/PQ/PV activities.
Bausch Lomb is one of the best-known and most respected healthcare brands in the world, offering the widest and finest range of eye health products including contact lenses and lens care products, pharmaceuticals, intraocular lenses and other eye surgery products. The company is solely dedicated to protecting and enhancing the gift of sight for millions of people around the world – from the moment of birth through every phase of life. Our mission is simple yet powerful: Helping you see better to live better.
Education:
Four-year college degree (BA/BS) in fields such as life or physical sciences, or engineering.
Experience:
2-4 years Quality experience. Experience with medical devices preferred. Strong verbal and written communication skills, ability to manage multiple priorities. Working knowledge of 21 CFR 820, ISO 13485, ISO 9001, Quality tools, and problem solving tools, statistical analysis.
Special Skills:
Quality Tools - Quality Planning, Costs, Assessment, Basic /or Advance Statistical Techniques, Tech Writing, Metrology & Calibration, Inspection & Testing, Sampling Principles & AQL, TQM, Six Sigma
Problem Solving Tools - Process Mapping, Histograms, FMEA, Risk Assessment, Cause & Effect Diagrams, PCDA, Pareto Analysis
Computer & Information Technology Skills – Windows, Word, Excel, Power Point, Project, Visio, statistical software (i.e. Minitab).
Specialized Training:ASQ Certified Quality Engineer or equivalent preferred.Job: Quality
