Description:

The Supplier Quality Engineer serves a key role for supplier onboarding activities for both sustaining and merger & acquisition (M&A) quality support. Interfaces with many functions of the business, both internal and external, including suppliers, quality, sourcing, regulatory, and operations, ensuring that the products and services provided by our global supply base continue to meet and exceed customer needs.

o Collaborates with suppliers to assure the quality of their products, materials, components and/or operations.

o Monitors supplier performance and supports efforts to develop and implement changes to improve the production process.

o Follows up with suppliers on quality deviations and ensures that solutions are identified and implemented.

o Collaborates with cross-functional and suppliers teams to address top quality issues.

o Own identified supplier driven non-conformances and manage the timely closure of NC's within Trackwise. Own or support identified supplier CAPAs and manage to timely root cause investigation, implementation and closure.

o Communicate & collaborate with suppliers regarding non-conformances, escalating supplier corrective action requests as required.

o Participates and may lead in the creation and/or review of new or modified procedures.

o Maintain KPIs for monitoring of supplier quality processes, perform analysis, and interpret trends, identifying and activating on appropriate actions as necessary.

o Applies statistical methods of analysis and process control to external operations.

o Support manufacturing transfers to/from other plants/facilities, executing appropriate quality activities.

o Lead quality issues with suppliers & partner with Internal Customers; Lead effective supplier containment and corrections/corrective actions

o Act as point of contact for Internal/ External Customer groups on key compliance issues related to assigned suppliers

Additional Skills & Qualifications:

o Bachelor’s Degree

o 3 years experience

Preferred Qualifications:

o Lead Auditor Quality Qualification either in ISO 9001, ISO13485, CFR820 or comparable industry standards and regulatory requirements

o Bachelor’s Degree in Engineering or Science-related field

o Understanding of US, EU and International Medical Device Regulations.

o Strong knowledge of Quality Concepts (e.g. Risk Management, NC/CAPA, Audits, Statistics).

o Must possess strong communication, project management and influencing skills as well as have the ability to manage multiple tasks simultaneously.

o Experience in working in a supplier quality setting and/or compliance risk situation.

o Good knowledge with GMP, ISO 13485, 21 CFR Part 820 standards.

o Good knowledge of FMEA, Validation Programs and SPC processes in a highly regulated environment.

About Actalent:

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.