Principal Operations Quality Engineer

GUERBET • Raleigh, NC

72d

About The Position

At Guerbet, we build lasting relationships so that to enable people to live better. This is Our Purpose. We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, digital and AI solutions, for diagnostic and interventional imaging. As a pioneer in the field of contrast products since the last 100 years, we continuously innovate to improve the diagnosis, prognosis and quality of life of patients. Customer Centricity, Cooperation, Audacity, Focus, and Responsibility are the values that we share and practice on a daily basis. Working at Guerbet is not only being part of a multicultural team with nearly 3,000 people across more than 20 countries, but it is above all about playing a unique role in the future of medical imaging.

Requirements

• Minimum BS/BA degree in Life Sciences or Business. MS preferred.
• Minimum 8-12 years' experience in a pharmaceutical setting.
• ASQ certified inspector/auditor preferred.
• Analytical knowledge of Microbiology and Chemistry is preferred.
• Good documentation skills with eye for details and ability to identify hidden problems within processes and systems.
• Ability to work in a fast-paced environment; Proficient in multi-tasking; Well organized and reliable for consistent decision making.
• Strong Technical Writing Skills; Competent with MS Office software environment; Ability to interact with all levels of the organization.

Responsibilities

• Lead position in the site execution of external audits from regulatory agencies (i.e SME, Inspection Room Representative). Position will take a lead role in the formulation of inspection responses and commitment completion follow-up.
• Assist in the department completion of trending and metrics (i.e Cost of Poor Quality, Key Performance Indicators, Quality Management Reviews, & Data Trend Analysis)
• Complete department requirements for site Annual Product Quality Reviews (APQRs). Must have the ability to assess shifts and trends, as well as associate CAPA response as it relates to data obtained.
• Ability to write, review and final approve site related complaints, exceptions, and CAPA RCA investigations within a timely manner. When needed, may also perform investigations within each of the compliance quality systems.
• Possess process technical knowledge and writing capabilities.
• Ability to lead site Kaizens or brainstorming initiatives.
• Ability to support site annual or non-routine GMP training.
• Primary designee for Quality Operations Manager in his/her absence.
• Proactively manage and maintain regulatory compliance (US/EU/WHO/Brazilian/Korean standards).
• Providing day to day supervision and oversight of Operations QEs.
• Performs other duties as assigned by management.

Benefits

• Continued personal development.
• Joining a global leader with recognized expertise in diagnostic and interventional imaging.
• Being part of a diverse team committed to improving quality of patient's life.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Computer and Electronic Product Manufacturing
• Education Level: Bachelor's degree
• Number of Employees: 1,001-5,000 employees