Job: Supplier Quality Engineer (SQA Services)
Supplier Quality Engineer will work with chemical and/or packaging suppliers on behalf of a Fortune 100 customer to close audit observations. The QE will communicate with suppliers regularly in order to ensure that the supplier tracks to committed timelines. The QE will review objective evidence provided by the supplier and determine if it addresses the observations. The QE will document closure of findings and completion of audit, escalating issues as necessary, working with business partners as needed, providing status to management, and recommending rating changes with the supplier. The QE may also own formal risk assessment and mitigation activities.
Qualifications and Requirements:
BS degree
· Minimum of 5 years of experience in a Quality Assurance role within a Pharmaceutical, Medical Device & Diagnostic, OTC Drug industry, Consumer Products and/or Food industry environment
· Direct experience in Supplier GMP auditing
· Broad experience with quality systems, including but not limited to validation, non-conformance, CAPA systems and investigations, laboratory controls, production and process controls (ICH Q7 and IPEC-PQG GMP guidelines, FDA CFR Part 110 cGMP is desired)
· Experience with documentation and technical writing skills, in a regulated compliance environment
· In-depth knowledge of Supplier Quality Management principles, expert auditing and problem solving skills, in-depth knowledge of Quality and operations systems and processes
· Demonstrated ability to identify compliance risks and assess business impact
· Strong influence and negotiation skills and leading without direct line authority experience
“Nice to Haves”:
· Quality Auditor or Lead Auditor certification is preferred
· Prior experience with FDA inspections is desirable
Tim Lebetsamer
Associate Development Manager
TimL@sqaservices.com
(310) 802-4438
