Quality Regulatory Affairs (QRA) Coordinator
Location: Redmond, Washington
About Our Client:
Our client has built a high-trust, people-first culture driven by real employee feedback and a commitment to innovation, collaboration, and performance. Known for fostering an environment where employees feel valued, supported, and empowered to grow, the organization continues to set itself apart as an employer of choice. Working here means joining a team of top technical professionals bringing cutting-edge products to the forefrontoffering driven individuals the opportunity to make a meaningful impact every day.
Key Responsibilities:- Coordinating PFA Executions according to defined strategies, procedures, and regulations.
- Overseeing and coordinating all field-related activities scoped within PFA Executions as a QRA Coordinator, PFA.
- Ensuring the PFA Executions are executed in compliance with regional regulations and guidance, primarily focusing on FDA requirements.
- Working directly with management to ensure timely notification to regulatory agencies.
- Reporting regularly to keep management informed of PFA Execution status.
- Serving as a member of the divisional PFA team to establish, implement, and maintain Global Regulatory and Quality processes and documents supporting our Global QMS.
- Maintaining standardized processes and procedures for executing field actions, including working with international partners to ensure effective field action completion.
- Maintaining PFA Execution tracking and documentation.
- Ensuring that all field activities adhere to relevant regulatory requirements, industry standards, and company policies.
- Providing advice on corporate PFA Execution policies, ensuring that the Stryker Redmond and Stryker Belfast PFA Execution Procedures are current and aligned with other Quality System Procedures.
- Developing and providing training for PFA Execution processes.
- Supporting internal and external audit activities related to PFA Executions.
- Communicating with regulatory agencies on notifications and statuses of PFA Executions.
- Providing updates to management on the status and completion of PFA Executions.
- Collaborating with internal stakeholders, such as PFA process leads, site execution owners, engineers, and technicians, to ensure seamless coordination and communication regarding field action deliverables.
- Maintaining a customer-centric approach by ensuring that field actions are completed promptly and meet or exceed customer expectations.
Qualifications:- Proven experience in administration, coordination, or inventory managementminimum of 2 years preferred.
- At least 2 years of experience in managing inventory or materials in a technical or healthcare setting, preferably with medical capital equipment or robotic systems.
- Familiarity with SAP, ServiceMax, or similar systems for inventory and traceability purposes.
- Strong collaboration and communication skills, with a big-picture mindset focused on customer service.
- NO C2C CANDIDATES
Interested Candidates please apply on our website at https://jobs.jblresources.com.
For more information about our services and great opportunities at JBL Resources, please visit our website: https://www.jblresources.com.
JBL Resources is proud to have earned the reputation of being a premier provider of top talent professionals in the fields of engineering, human resources, logistics, operations, and supply chain management. As specialists in both permanent placement and contract services, our mission is to help companies and individuals become all they were created to be.
**JBL is an Equal Opportunity Employer and E-Verify Company