Quality Engineer II

At Avantor, people are the most important part of our success because they drive our global performance. That's why our Operations, Lab Services, Sales, and many other Avantor teams rely on our talent acquisition initiatives to attract, engage and hire the right talent. Avantor's Quality Engineering vertical is a crucial part of this mix, enabling all our internal teams worldwide to grow beyond their limits.

The Quality Engineer II works independently under close supervision, apply, and maintain quality evaluation and control systems/protocols. Implement methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. Analyze inspection and testing processes, mechanisms, and equipment. Conduct quality assurance tests and performing statistical analysis to assess the level of control and manage product quality risks.

This position will report into the QA Manager and will report to our Morrisville, NC location.

Who you are:

• Education: Bachelor's degree in a natural/life science field with knowledge and experience in one of the following areas: medical device, biotech, or pharmaceutical industry is preferred.
• Experience: 3-5 years of experience in quality engineering, quality assurance, or similar role.
  • 3 - 5 years of proven experience conducting and supporting audits.
  • Collaboration Tool: Must be proficient in MS Office (Word, Excel, Access)
  • Certified Quality Engineer (CQE)/Certified Quality Auditor (CQA) certification preferred
  • Technical writing skill set is required.

Who you are:

• Demonstrated experience or knowledge in conducting root cause analysis as it relates to investigationsand CAPAs.
• GMP knowledge required.
• Experience using an ERP system.
• Experience with using a QMS.
• Advanced analytical and problem-solving skills required.
• Advanced project management skills preferred.
• Knowledge and experience utilizing Microsoft Outlook, Word, Excel, and Access, or equivalent software packages.
• Knowledge of lean methodologies
• Experience with creating, developing, and executing protocols, method transfer and training programs preferred.
• Experience with internal and external audits
• Training experience preferred.
• Able to collaborate with all levels of employees is required.
• Knowledge of inspection tools and techniques.
• Good interpersonal skills
• Good attention to detail
• Good mathematics skills.
• Ability to read, understand, and follow procedures.
• Working knowledge of ISO 9001:2015 Standard.
• Self-motivated and ability to work independently and with a team.
• Good written and oral communication skills are required.
• Must be detailed oriented, with strong organizational skills, ability to multi-task, prioritize workload and work independently to meet commitments with minimal direction is required.

How you will thrive and create an impact:

• Work independently to initiate, investigate and support quality Events, Complaints and CAPA's and SCARS.
• Coordinate, and maintain customer complaint & CAPA management system, validations for all departments, along with the Calibration Program and the Environmental Monitoring Program.
• Write and implement methods and procedures for supporting the quality management system.
• Review and approve quality assurance procedures and reports.
• Coordinate the implementation of process controls to support manufacturing operations.
• Review and approve methods and procedures for supporting the quality management system.
• Support the implementation of Avantor Business Solutions (ABS) initiatives.
• Participate in investigation, resolution, and prevention of product and process non-conformances.
• Provide support for validations.
• Lead and participate in audits (both internal and supplier) and support compliance with applicable Regulatory Quality System standards.
• Participate in supporting quality decisions.
• Support, coordinate and maintain service provider qualification and monitoring.
• Conduct root cause analysis investigation and perform risk assessment and evaluations to identify appropriate corrective action.
• Conduct quality assurance tests and performs statistical analysis to assess the level of control and manage product quality risks.
• Employ Quality Engineering tools and techniques to develop, align and optimize systems and processes.
• Participate and support Tier Daily Management
• Write reports and facilitate it's use for supporting the quality management system.
• Support service provider qualification and monitoring.
• Ensures cleanliness of work areas.
• Performs other duties as assigned by Manager.
• Follows applicable safety procedures.

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 characteristic protected by federal, state/province, or local law.

If you need a reasonable accommodation for any part of the employment process, please contact us by email at recruiting@avantorsciences.comand let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.

For more information about equal employment opportunity protections, please view the Know Your Rights poster.

3rd Party Non-Solicitation Policy:

By submitting candidates without having been formally assigned on and contracted for a specific job requisition by Avantor, or by failing to comply with the Avantor recruitment process, you forfeit any fee on the submitted candidates, regardless of your usual terms and conditions. Avantor works with a preferred supplier list and will take the initiative to engage with recruitment agencies based on its needs and will not be accepting any form of solicitation.