The Supplier Quality Engineer will act as the quality subject matter expert on cross-functional project teams to determine and conduct activities to assist in qualifying new suppliers. These activities include assessing quality system information for new suppliers through questionnaire review and auditing (both GMP and Non-GMP), assessing and tracking supplier action plans, working the purchasing/sourcing teams to negotiate Quality Responsibility Agreements with suppliers to ensure expectations are mutually understood and agreed upon, and reviewing and approving material specifications. The Supplier Quality Engineer will also support maintenance of existing supply base through review and approval of change control documentation and material specification revisions, periodic supplier quality system assessment, participation in Quality Responsibility Agreement negotiation, and in supplier nonconformance investigations. The Supplier Quality Engineer will identify and recommend solutions to improve the supplier qualification and management process and system.

What we are looking for:

• BS Degree in Engineering or Life Science (A focused degree in Chemistry, Engineering, Microbiology, Biology, or another closely related technical discipline is preferred).
• 5 -7+ years of applicable experience in quality assurance and supplier auditing/oversight.
• American Society of Quality (ASQ) certification as Certified Quality Auditor (CQA), Certified Quality Engineer (CQE) and/or Six Sigma Green Belt or Black Belt strongly desired.
• Knowledge of the principles and practices of Quality Assurance in the consumer, pharmaceutical, or medical device industry is required.
• Knowledge of GMP requirements and current FDA enforcement regulations is preferred.
• Proficient in quality analysis tools such as Fishbone, 5-why’s, SPC, PFMEA etc. Strong problem-solving skills with ability to teach basic problem solving techniques and facilitate problem solving team events.
• Experience in developing product certification processes and vendor quality measures.
• Strong engineering analysis skills
• Strong Computer skills
• Strong communication, presentation, and team skills.
• Strong organizational and time management skills.
• Excellent oral and written communication skills
• Self-motivated with a high level of initiative.
• Strong data analysis and reporting skills.
• Knowledge of Quality System, FDA, ISO regulations, CAPA system, GMP practices.

How you would make the impact:

• Assess potential suppliers for manufacturing, technical, and quality capabilities versus Avantor specifications and quality expectations.
• Interface with purchasing and sourcing departments with regards to supplier performance.
• Maintain eQMS system requirements for supplier profiles and verification of required documentation for supplier qualification status.
• Prepares documentation and necessary data to support external and internal audits.
• Schedule, conduct, and complete supplier quality system audit and audit reports as applicable.
• Collaborates with suppliers to develop corrective actions from audit findings and drives completion of tasks.
• Validate effectiveness of SCAR root causes through on-site visits to suppliers as needed.
• Facilitates resolution of problems related to misunderstanding or misinterpretation of product specifications as applicable.
• Participates in project team meetings to ensure quality and operational procedures and requirements are clearly understood and communicated to the supplier.
• Provides technical input for strategic sourcing projects, including evaluation of supplier capability, specification review, product implementation and product transition for new and current products.
• Identify areas with suppliers for process improvement and value enhancement opportunities.
• Respond with a high sense of urgency to quality issues and escalate / communicate effectively.
• Performs 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 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.com and 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.

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