Ensuring and maintaining product safety and efficacy for Werfen's medical devices and IVD systems
Requirements
- Advanced knowledge of current compliance requirements (e.g., US Quality System Regulations (QSRs), EU in vitro Diagnostics Regulations (IVDR), ISO 13485, ISO 14971, ISO 17025, IEC 60825 or other regulations and standards)
- Advanced knowledge in design controls, risk assessment and analysis, root cause investigations, trend analysis, statistical sampling, change control assessment, nonconformance assessment, design of experiments, project management, data mining, requirements analysis, and traceability
- Advanced knowledge of both hardware and software engineering principles, as well as the specific requirements and challenges associated with IVD systems, including assays
- Working knowledge of fluidics in diagnostic devices, including understanding the principles of fluid dynamics and how they apply to the operation and integration of fluidic systems within diagnostic instruments
- Working knowledge in mentoring and technical development of junior staff
- Advanced ability to function effectively with ambiguity in a rapidly changing environment to organize and complete multiple tasks as a team member and/or as an individual contributor in a timely, accurate manner under general supervision
- Advanced skills in Microsoft Office Suite: Word, Excel, Access, Outlook, Power Point, Visio, and Adobe Acrobat
Responsibilities
- Is Quality Engineering lead on design and development projects, product and process changes, risk management, root cause investigations, validations, process capability, and trend analysis
- Represent Quality Engineering in Design and Development activities through launch, Product and Process Changes, sustaining On-Market safety and efficacy, and Post-Market Surveillance endeavors
- Acquire and maintain current knowledge of applicable requirements for risk management activities and produce audit ready Risk File documents in compliance with the requirements of current international risk management standards and regulations
- Perform independent quality review and evaluation of change orders including related data for scientific approach, presence of supporting objective evidence, technical validity, accuracy, completeness, and compliance to applicable regulations and standards
- Assist Quality Engineering management with development of strategic and tactical options for accomplishing company goals and initiatives
- Identify applicable processes for new standards and regulations
- Ensure departmental records, QMS procedures, and controlled documents comply with applicable regulations and standards
Other
- Bachelor’s degree in a life science, engineering, or equivalent required
- Ten (10) or more years of work experience in IVD or medical device industry required
- Seven (7) year of work experience in Quality Engineering in the designated specialty of Process Quality Engineering, Supplier Quality Engineering, Design Quality Engineering for laboratory instruments (hardware and software), Design Quality Engineering for medical software, Design Quality Engineering for IVD assay reagents, Design Quality Engineering for IVD system integration, Risk Quality Engineering, or related functions
- Project management experience preferred
- Travel requirements: If required, provide approximate percentage of travelling time
