The Sr. Staff Quality Engineer is a contract role that will be responsible for leading a project to improve the Quality and compliance of the Dispensing Implementation process. This role will work with the Dispensing Implementation teams to document and suggest compliance-related improvements or changes to that process. The intent of this role is to bring the Dispensing Implementation process to a state of compliance that would pass an external regulatory agency inspection.
Duties include: • Evaluating the Dispensing Implementation process against regulatory requirements associated with CFR 820.200 and international regulatory requirements. • Leading a cross-functional effort to develop and execute the plan to improve the compliance state of the process. • Communicate weekly status to the Quality and SDS leadership teams. • Compliance to all service record documentation requirements.
Job Family Summary:
Quality Engineering is responsible for product and service quality evaluation and control. Works cross-functionally in the development and/or maintenance of products or services.
What is expected of you for success in your role: • Demonstrates strong knowledge of quality engineering policies, principles and best practices • Understanding of regulatory and international standards requirements including 21 CFR 210, 211, ISO 13485, ISO 14971 to support work with little or no supervision • Represents Quality organization on project Core Team(s) • Apply Quality Engineering tools (Sampling Plans, Root Cause Analysis, Statistics, etc...) • Acts as a resource for colleagues with less experience • Collaborates across functions and TGS to drive effective and confident compliance.
Qualifications: • Qualified candidates will have a Bachelor's degree in a relevant degree field (engineering) and minimum 10 years' experience in a Quality role in FDA regulated environments. • Demonstrated experience with the Quality requirements for installation of medical devices is required. • Extensive demonstrated history completing quality/compliance improvement projects in an FDA regulated environment is required. • Demonstrated experience with installation of medical devices with embedded software is strongly preferred. • Attentiveness to details with strong organizational skills • Ability to work proactively and independently • Ability to multi-task and efficient in time management • Excellent verbal communication and interpersonal skills with the ability to work in a team environment • Proficiency in Excel, Word, and other desktop/general business systems • Quality Engineering Certification (ASQ) or equivalent (preferred)
kindly share resume at gaurav@stellarconsulting.com or call me at 678-935-7045 to discuss more!