Quality Engineer II

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Date: Jun 11, 2024

Location:

Raleigh, US

Job Type: Long-term/regular

Quality Engineer II M/F (29270)

At Guerbet, we build lasting relationships so that we enable people to live better.

We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, as well as digital and AI solutions for diagnostic and interventional imaging. As a pioneer in contrast products for the last 95 years, we continuously innovate.

Customer centricity, Cooperation, Audacity, Focus, and Responsibility are the values that we share and practice.

For more information on Guerbet, go to www.guerbet.com and follow Guerbet on LinkedIn, Twitter, Instagram, and YouTube.

WHAT WE'RE LOOKING FOR:

We are seeking a proactive and dedicated individual to join our QA Compliance department in a mid-level position. This role is pivotal in maintaining compliance levels across our plant, working cross-functionally with various teams. While this position does not involve direct reports, it offers the opportunity to make a significant impact on our operations and quality assurance processes. This is a day shift position at our Raleigh, NC site.

YOUR ROLE:

As part of your responsibilities, you will:

• Investigate and resolve site-related complaints promptly.

• Handle site-related exceptions (major and minor) based on departmental needs.

• Execute or assist with simplified and standard CAPAs.

• Participate in internal audits across the plant, including routine clean room behavior audits.

• Support the execution of external audits from regulatory agencies.

• Assist with trending and metrics for the department (e.g., Cost of Poor Quality, Key Performance Indicators, Quality Management Reviews, Data Trend Analysis).

• Compile data for department requirements related to site Annual Product Reviews (APRs).

• Contribute as a team member to Kaizens or brainstorming initiatives for continuous improvement.

• Support or conduct non-routine GMP training or awareness sessions related to investigations or complaints.

• Revise SOPs as needed and track the performance of assignments to completion.

YOUR BACKGROUND:

Education

• A BS/BA degree in Life Sciences or Business is preferred.

Experience

• A minimum of 4-5 years' experience in a pharmaceutical setting is preferred. Being an ASQ certified inspector/auditor is a plus.

Skills/Competencies

• We're looking for someone with good documentation skills and an eye for detail. The ability to work in a fast-paced environment is crucial. Familiarity and skilled competency with computers and MS Office software environment are required. You should also be able to seek out and apply the best quality assurance methods and practices in support of Quality objectives

EQUAL EMPLOYMENT OPPORTUNITY:

Guerbet is an Equal Opportunity Employer. As an organization, we believe that no individual should be discriminated against because of their differences, which includes the following: age, disability, ethnicity, gender, gender identity and expression, religion, or sexual orientation. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, or any other basis as protected by federal, state, or local law. Guerbet is committed to diversity, equity, and inclusion.

Guerbet provides accommodations to applicants and employees with disabilities. If you need an accommodation to apply for a position, please send an email to careers@guerbet.com or you can also call this number +19843443717

WHY GUERBET?:

• 4 weeks of PTO

• Insurance benefits start date of hire

• Competitive 4% 401K match + 2% profit sharing contribution

• Tuition reimbursement program for ongoing education

• Paid time off for select volunteer opportunities