Senior Quality Engineer

Senior Engineer, Quality (Hybrid)

Summary

This role represents the Bracco Diagnostics Inc. Quality Organization in coordinating, performing, and maintaining quality activities in accordance with required cGMPs, Standard Operating Procedures, and company and regulatory requirements. This role supports the implementation and continuous improvement of quality systems, manages quality investigations, leads risk assessments, and contributes to regulatory readiness and product safety. The ideal candidate is detail-oriented, highly analytical, and experienced in working within FDA- and ISO-regulated environments. This role is hybrid and will be working out of our Princeton, NJ office 3 days per week.

Main Responsibilities, Activities, Duties and Tasks

• Quality Lead for projects.
• Ensure activities comply with all required quality standards and regulations
• Implement required changes into the Quality Management System
• Provide technical support for quality related tasks
• Ensure the changes are properly implemented at contract manufacturers, as required
• Key contributor for quality systems monthly, quarterly, and yearly quality management system metric collection and reporting
• Quality Lead for product sample coordination. This includes working with Sales and Marketing and a Third-Party service provider to ensure professional and demonstration sample product is distributed meeting all required quality standards and regulations. Activities include:
• Reviewing product sample requests and the product sample process to ensure compliance
• Working w/ Sales & Marketing to verify monthly and yearly sample request consolidation
• Working to resolve sample product shipment & receipt issues as applicable
• Reviewing annual quality agreements, yearly statements of work, & business contracts to ensure compliance
• Key contributor for inspection readiness, which includes activities for preparation, logistics, and implementation to support the entire inspection process
• Key contributor to provide support in the facilitation of continuous improvement throughout BDI Quality, which includes support in defining and implementation of initiatives, while working with Bracco Corporate Quality Management and various functions within BDI
• Assist in supporting product material master information, as it relates to BDI Quality, and support receipt and distribution inquiries at BDI and Bracco affiliate warehouses
• Key contributor for quality system related continuous improvement activities

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or a related technical field (advanced degree a plus).
• 5 years of experience in a quality engineering or quality assurance role in the pharmaceutical or medical device industry.
• Strong written and verbal communication skills, with the ability to present and explain complex issues clearly.
• Computer experience: PC software, word processing and spread sheet e.g., Word, Excel, Power Point, Share Point, Microsoft Teams, SAP, and Power BI
• Experience with utilization of AI (Artificial Intelligence) tools to facilitate KPIs (Key Performance Indicators) is a plus
• Knowledge of the current cGMPs such as 21 CFR Part 210 & 211, ISO 13485, ISO 14971, QSR Part 820
• Experience in FDA & Notified Body inspections is a plus
• Ability to influence for results
• Ability to work cross-functionally across multiple departments and organizations
• Strong organizational skills, detail oriented and able to communicate effectively
• Strong interpersonal skills and ability to work in a team environment

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Travel: 5-10% of time

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The position is home office based.

This position is a Hybrid position. Employee is required to be in the office three (3) days a week, Tues-Thurs.