Scope of the Role: The Quality Systems Analyst III, leads the planning, development, and implementation of effective quality systems. This position will work closely with management and end users to develop, implement, and support business applications, focusing on the continuous improvement of these systems and meeting the operational and strategic needs of the organization. The Quality Systems Analyst reports to the Quality Manager.
Duties and Responsibilities:
Lead design sessions in prototyping new systems for the purpose of enhancing business processes, operations, and information process flow.
Lead implementation of Electronic Quality Management System and associated modules
Ensure compliance to ISO 13485, 21 CFR part 820, MDSAP and other regulatory/legal requirements
Work with decision makers, process owners, and end users to define business, financial, and operational requirements, and identify and resolve systems issues.
Automate the required elements needed for the regularly scheduled MRM, AOD and support live monthly scorecards using an approved software solution.
Develop and maintain a communication tool for direct/in-direct personnel so they can be aware of positive /negative issues we have our valued customers, suppliers and announcements on areas of improvement.
Work with current process owners, converts existing process to electronic systems and train owners to take ownership of their respective areas.
Use lean and six sigma principles to improve the current quality systems and its processes
Lead software validation efforts for new electronic processes
Work closely with the customer and develop quality assurance plans for new customers and improve process efficiency for existing customers.
Provide support in entering of RMAs, CAPA, monitoring of DCRs and Deviations, and PPM tracking.
Assist in document control functions by creating new operating procedures, work instructions, forms etc.
Responsible for supporting Engineering and Manufacturing to resolve technical issues and implement corrective and preventive action (CAPA)
Assist with site wide SPC implementation and programming CMMs as needed.
Perform validation activities such as TMVs, process validation, data analysis.
Analyse data gathered from multiple sources, reconcile differences, and identify systems or procedural modifications necessary to correct issues.
Assist in the development of project plans, associated communications materials, and training documents.
Effectively manage project team members and contractors and influence them to take positive action and accountability for their assigned work.
Create customer dashboards and reports on key business process.
Coordinate and perform in-depth tests, including end-user reviews, for modified and new systems, and other post-implementation support.
Provide orientation and training to end users for all modified and new systems.
Qualifications and Skills:
High school diploma or GED with 10+ years of relevant experience
Bachelor’s degree in engineering, Computer Science or equivalent is preferred with 5+ years of relevant experience. Bachelor’s degree can be substituted with 4 additional years of relevant experience.
Minimum 3-5 years related experience in a manufacturing environment.
Strong understanding of quality processes such as Document Control, CAPA, NCRs, Change Control etc
Proven experience with development and implementation of ERP/eQMS Software, IQMS preferred.
Demonstrated project management skills.
Excellent analytical, mathematical, and creative problem-solving skills.
Excellent written and oral communication skills.
Experience working in a team-oriented, collaborative environment.
