Quality Engineer II

The Opportunity:

Avantor, a Global Fortune 500 company is looking for a dedicated Quality Engineer to optimize our Quality organization.  This Morrisville, NC based role is full-time.

If you have quality engineering experience – let’s talk!

Minimum Education: Bachelor’s Degree (in a related scientific discipline e.g., Pharmacy, Chemistry, Biology, Biotechnology)

Required experience (3+ years):

• Conducting and facilitating deviations, complaint investigations and CAPAs using root cause analysis tools such as 5 whys, 6 M’s etc.

• Facilitating, conducting, and supporting Regulatory and QA Customer Audits.

• Participating in investigation, resolution, and prevention of product and process non-conformances.

• Good technical writing skills

• Strong analytical and problem-solving skills

• Excellent interpersonal skills with the ability to serve as a liaison with Internal departments and customers.

• Able to demonstrate strong business acumen, good writing and oral communication skills.

• Demonstrate the ability to collaborate with multiple levels of employees 

• Detailed oriented/ organizational skills, multi-tasking, prioritizing workload and working independently on Complaints, Deviations, SCAR’s and CAPA’s.

Preferred Experience:

• Collaboration Tools (e.g., MS Office)

• CQE/CQA certification

• Advanced analytical and problem solving.

• Advanced project management

How you will thrive and create an impact:

As a major team contributor, the Quality Engineer will:

• Work independently to initiate and investigate quality Events, Complaints and CAPA's and SCARS.

• Utilize root cause analysis and risk assessment tools to perform investigations and identify appropriate corrective action.

• Coordinate and maintain customer complaint & CAPA management system, along with the Calibration Program and the Environmental Monitoring Program.

• Conduct audits and coordinate compliance with ISO regulations standards

• Collect, review, and interpret data for trend report, metrics, quality system review and complaints.

• Review and approve quality assurance procedures and reports.

• Work with QA Manager to maintain SOPs and Quality Management System.

• Provide support for customer, regulatory, and internal audits.

• Coordinate in the implementation of procedures, protocols, process controls and Quality Management Systems.

• Coordinate and implement continuous improvement methodologies.

• Participate on teams in supporting quality decisions and practices.

• Support process changes and new product development

• Collaborate with cross-functional teams to prepare for and participate in regulatory inspections and internal and external audits, addressing any findings or observations.

• Participate at the Quality and/or Management review meetings.

• Perform other duties as assigned.

Disclaimer:

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. Avantor is proud to be an equal opportunity employer.

Why Avantor?

Dare to go further in your career. Join our global team of 14,000+ associates whose passion for discovery and determination to overcome challenges relentlessly advances life-changing science.
 
The work we do changes people's lives for the better. It brings new patient treatments and therapies to market, giving a cancer survivor the chance to walk his daughter down the aisle. It enables medical devices that help a little boy hear his mom's voice for the first time. Outcomes such as these create unlimited opportunities for you to contribute your talents, learn new skills and grow your career at Avantor.
 
We are committed to helping you on this journey through our diverse, equitable and inclusive culture which includes learning experiences to support your career growth and success. At Avantor, dare to go further and see how the impact of your contributions set science in motion to create a better world. Apply today!

EEO Statement:

We are an Equal Employment/Affirmative Action employer and VEVRAA Federal Contractor. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected Veteran status, or any other characteri