Quality/Regulatory Business Systems Analyst
Redmond, Washington | Contract
Position Title: Quality / Regulatory Business Systems Analyst
Position Description: Our client is seeking a Quality /Regulatory Business Systems Analyst for an exciting contract position at their campus in Redmond. The Position Communicates and collaborates with Team Members and 3rd party vendors to conduct analysis of complex Quality and Regulatory business problems to be addressed via process and technology solutions. Design and implements Quality System and Regulatory business processes to support long term, effective, cross functional operations that are compliant with US and International regulations such as Universal Device Idenficiation (UDI), Premarket approval (PMA), and European Union Medical Device Regulations (EU MDR). Enact controlled processes and methods to correct Quality System and Regulatory data quality issues. Keep metrics of data quality and data quality improvement to demonstrate effective corrections and corrective actions.
- Determine requirements for new and updated Quality/Regulatory business processes
- Construct and implement process designs for new and updated Quality/Regulatory business processes
- Work cross functionally across multiple functions to make sure all stakeholders needs are addressed
- Specify requirements, approve IT system designs, and write test protocols for IT systems and tools needed to support Quality/Regulatory business processes
- Develop and deliver software validation documentation per requirements of the non-product computer systems validation requirements.
- Perform data corrections to correct and maintain legacy Quality and Regulatory data
- Establish metric system for measurement and management of Quality and Regulatory data quality
- Perform other related duties as assigned.
- Bachelor’ s degree
- At least 2 years’ experience working in Pharma/medical device industry.
- At least 3 years of direct experience with UDI, regulated systems and documentation.
- At least 5 years of experience implementing processes of increasing scope which have spanned multiple disciplines including Quality, Regulatory, Sourcing, Engineering, Production and IT
- Knowledge of US and international regulations such GMP, UDI, and EU MDR
- Requires an in-depth knowledge of the system development life cycle
- A demonstrated ability in creation of requirements and test script documents
- Demonstrated ability to document as-is business processes and to articulate designs using flow charts, swim-lane diagrams, value stream maps or other process documentation technique.
- Must show strong judgment and time management skills
- Must understand the components of running a fiscally successful project
- Excellent Communication (Verbal and Written), analytical and problem solving skills
- Computer training including use of the internet
- Intermediate to advanced knowledge of Microsoft Office applications (Outlook, Word, Excel, PowerPoint, Access)
- Experience with QAD
- Experience implementing business and IT processes to support UDI
- Lean process development
- Proficient task management including prioritization skills
- Self motivated, organized, efficient and process oriented
- Team player
- Strong work ethic
- Works well under pressure in a dynamic environment
- Tactful, exercises independent judgment and discretion
- Professional presentation and strong interpersonal communications skills
Benefits Package: Protingent offers competitive salary, 100% paid health insurance, education/certification reimbursement, pre-tax commuter benefits, Paid Time Off (PTO) and an administered 401k plan.
About Protingent: Protingent is a niche provider of top Engineering and IT talent to Software, Electronics, Medical Device, Telecom and Aerospace companies nationwide. Protingent exists to make a positive impact and contribution to the lives of others as well as our community by providing relevant, rewarding and exciting work opportunities for our candidates.