Title : Sr Staff Quality Engineer
Duration: 12 + months Contract
Location: San Diego, CA 92121
The ideal candidate will have experience with installation of embedded software medical devices. The candidate will be working with me to improve the compliance level of BD's Dispensing implementation teams. This person must have strong FDA medical device experience and understand the requirements of 21CFR820.200. This person will be working with a cross functional non-Quality team to understand and document the process and, if appropriate, suggest improvements to that process.
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.
Adherence to BD Inspire Quality Processes
Driving effective and efficient installation and implementation execution.
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)
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