Senior Staff Quality Engineer (Strong Medical Device Exp) Onsite

Job Description

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.

• 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.
• Adherence to BD Inspire Quality Processes
• Driving effective and efficient installation and implementation execution.

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)