We are hiring a Quality System Data Analyst to join our Global Quality Systems Team. Your main tasks will include collecting and performing detailed data analysis, and documenting QMS processes.
To succeed in this role you should have a natural analytical way of thinking and the aptitude for continuous improvement.
You should also embody the ability to manage competing and shifting priorities. This is a high visibility role; therefore, you will need to be both professional and self-assured.
Facilitating ongoing reviews of QMS processes and developing optimization strategies.
Developing QMS KPI metrics.
Conducting meetings and presentations to share ideas and findings.
Communicating insights and plans to cross-functional team members, management and executive leaders.
Gathering critical information for monthly and quarterly meetings with various stakeholders and producing useful reports and presentations.
Working closely with sites, legal manufactures, and managerial staff to ensure consistent and timely data collection.
Supporting projects, developing project plans, and monitoring performance.
Updating, implementing and maintaining procedures.
Prioritizing initiatives based on QMS needs and requirements.
Monitoring deliverables and ensuring timely completion of projects / tasks.
Support eQMS system and on-going business administration of the eQMS for Quality System elements including Non-Conforming product / Deviations, CAPAs, Audits, Complaints, Supplier, Document, Change and Training Management
Implement Key Performance Indicators / Metrics to drive on-going evaluation help identify improvement opportunities and high performance decision making utilizing the eQMS systems
Evaluating QMS processes, anticipating requirements, uncovering areas for improvement, developing and implementing solutions
or degree (Business, Engineering or other applicable Science based field)
Licenses / Certifications
Auditor, ASQ or PMP certification Desired
Minimum 2 Years of quality experience in a medical device or pharma industry.
Experience in utilization of electronic and paper QMS systems
Experience with complaints processing, Non Conformance and CAPAs
Have lead complex projects with multiple inputs, requirements and locations
Experience with management of change and influencing others without direct leadership
Able to communicate effectively across global network with all levels form Executive management to entry level plant based employees
Can execute effectively in a fast paced environment with multiple projects and initiatives running in parallel
Delivers on commitments under self direction with minimal supervision
Proficient in MS Office, Document Control Software
Prior audit and CAPA experience.
Proficiency in English