HireDiversity

Raritan, NJ, US

Senior Engineer, Safety Risk Management and Surveillance (SRMS)-7523130111

Description

Ortho Clinical Diagnostics, Inc., a Johnson & Johnson company, is recruiting for a Senior Engineer, Safety Risk Management and Surveillance (SRMS) to be located in Raritan, NJ.

Ortho Clinical Diagnostics is a leading provider of in vitro diagnostic products and services, offering accurate, timely, and cost-effective solutions for screening, diagnosing, monitoring and confirming diseases. The company serves the global clinical laboratory and transfusion medicine community, and is committed to providing customers with products, services and process solutions to make labs more efficient in delivering the quality test results doctors and patients need.

The Senior Engineer, Safety Risk Management & Surveillance (SRMS) performs analysis of customer complaint data in a highly independent basis and identifies product quality trends, provides inter-departmental feedback for investigation and resolves product quality issues. Focus is on complaint vigilance, regulatory compliance and escalation of post market quality issues. This individual will perform in accordance with Company and Corporate policies, regulatory requirements, and franchise strategies. He/she will lead vigilance reporting, trending and signal detection, and health hazard evaluations in conjunction with Medical.

The Senior Engineer (SRMS) provides oversight of product quality review and field actions. He/she is responsible for establishing and executing post market surveillance process and analytics with a focus on safety signals. Collaborates with cross functional groups to drive process improvements and regulatory compliance. Leads effective and timely communication and appropriate escalation of quality issues based upon surveillance data. Leads quality review and participates in field action decisions. Communicates safety trends and recommends potential resolutions and/or actions. Prepares and leads presentation of complaint data for management review. Ensures departmental policies and procedures are in place to deliver to company goals and objectives and that meet regulatory compliance requirements. Establishes, implements, and updates complaint handling policies and procedures in conjunction with management and cross functional teams. Provides leadership, coaching, and mentoring to fellow colleagues.

The Senior Engineer (SRMS) is responsible for workflow and training as Subject Matter Expert. Ensures compliance with training to perform their assigned job functions. Supports complaint audit activities and leads as Complaint Handling Unit subject matter expert for regulatory inspections. Interacts with multiple functions to drive complaint investigations, CAPA and customer resolution. These functions include, but are not limited to, Customer Technical Support (CTS), Quality, R&D, Operations, and Global Publications Communication Implementation (GPCI). Participates in follow up meetings with customers as the Quality representative for the complaint process, as requested.

J2W:LI

Qualifications


Requires a minimum of a Bachelor Degree in Mechanical Engineering, Biomedical Engineering, or other relevant Life Sciences degree with a minimum of 4 years of relevant experience OR a Master Degree in Mechanical Engineering, Biomedical Engineering, or other relevant Life Sciences degree with a minimum of 2 years relevant experience. Experience in Blood Banking preferred. Donor screening experience is preferred. Experience with working with cross-functional teams, investigative techniques, writing and working closely with documentation is required. Familiarity with the auditing process, and previous experience answering FDA inquiries is preferred. Six Sigma Process Excellence is preferred. Familiarity with ID-Micro Typing SystemÔ Gel Cards, ORTHO® Summit Processor , and/or ORTHO ProVue® Analyzer is preferred. Proficiency in utilizing the Microsoft office Suite of applications (including Outlook, Word, Excel, PowerPoint etc) is required. The ability to travel up to 10% is required. This position is located in Raritan, NJ.

BE VITAL in your career; be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

Primary Location:North America-United States-New Jersey-Raritan
Organization: OCD Inc. (6118)
Relocation: Eligible
No