Job Description

SUMMARY:

The Quality Engineer is responsible for managing resources and/or staff to establish functional goals and to meet assigned objectives related to quality engineering activities including customer satisfaction, product quality and process reliability, design validation and transfer, process and change validation, complaint and non-conforming product investigation and corrective and preventive action.  Strong experience in IVD and/or Pharmaceuticals is required.  

DUTIES/RESPONSIBILITIES:

·         Work with Senior Leadership and cross-functionally to establish strategies, priorities and goals for process and equipment validation, process reliability, risk management, failure analysis, trend analysis, statistical quality and process control; ensure initiatives are successfully implemented.

·         Develop and implement process and equipment validations and qualifications supporting new product development, (contract) manufacturing transfer, on-going improvement

·         Identify and eliminate waste; maintain sustainable results

·         Understand customer needs; translate needs into actions for quality and process improvement

·         Support implementation of strong long-term quality systems and controls

·         Support fundamental and controlled quality improvements

·        Ensure appropriate statistical tools and techniques are followed

·         Maintain professional and technical knowledge

·         Ensure cost effective measures and budget compliance within the function; develop cost saving initiatives to meet or exceed financial performance requirements

·         Lead and motivate staff; promote employee involvement, operational excellence, internal career development, and foster positive organizational culture

·         Exercise good judgment within defined policies and procedures; develop and implement process changes that foster improvements and ensure objectives are met

·         Identify, review and analyze issues within the function; develop and implement goals and changes that foster improvements and ensure objectives are met  

Qualifications

·         Bachelor’s degree (technical discipline) or equivalent, plus a minimum of five (5) to seven (7) years previous progressive experience; quality and process improvements, project management and business process analysis experience within a IVD or pharmaceutical environment strongly preferred

·         Previous supervisory/management experience desired

·         Excellent knowledge of quality engineering principles including risk management, failure analysis, process validation, process reliability, trend analysis, statistical quality control, statistical process control and descriptive statistics

·         Knowledge of process management methodologies required

·         Must be able to develop and deploy design of experiment tools/techniques

·         Knowledge of quality analysis tools/techniques such as Pareto chart, run charts, scatters diagrams, regression analysis and diagrams is required

·         Knowledge of quality improvement team facilitation tools/techniques such as agenda planning, group facilitation and decision-making, brainstorming, group effeminizing and prioritizing is required

·         Excellent planning, problem solving and organizational skills required

·         Previous experience working on projects and issues with large impact preferred  

·         Strong focus on collaboration and team work

·         Excellent technical writing and communication skills required

Additional Information

APPLICATION PROCESS

Qualified candidates should submit a resume and cover letter. The cover letter should include information on how your previous experience relates to the job requirements and your availability. Specific examples are of interest. You will not be considered without a cover letter.

All your information will be kept confidential according to EEO guidelines.