A-Line Staffing is now hiring Sr. Staff Quality Engineer in San Diego CA 92121. The Sr. Staff Quality Engineer would be working for a Major Medical Device company and has career growth potential.

Sr. Staff Quality Engineer Highlights:
• Pay Range: $69.44 Hourly

Sr. Staff Quality Engineer Responsibilities:

• Lead a project to improve the Quality and compliance of the Dispensing Implementation process.
• Work with Dispensing Implementation teams to document and suggest compliance-related improvements.
• Evaluate the Dispensing Implementation process against CFR 820.200 and international regulatory requirements.
• Lead a cross-functional effort to develop and execute a compliance improvement plan.
• Communicate weekly status updates to the Quality and SDS leadership teams.
• Ensure compliance with all service record documentation requirements.
• Adhere to BD Inspire Quality Processes.
• Drive effective and efficient installation and implementation execution.

Sr. Staff Quality Engineer Required Qualifications:

• Bachelor’s degree in a relevant engineering field.
• Minimum of 10 years of experience in a Quality role within an FDA-regulated environment.
• Demonstrated experience with Quality requirements for medical device installation.
• Extensive experience in quality/compliance improvement projects in an FDA-regulated setting.
• Strong understanding of regulatory and international standards (21 CFR 210, 211, ISO 13485, ISO 14971).
• Experience with installation of medical devices with embedded software (strongly preferred).
• Proficiency in Excel, Word, and other business systems.
• Quality Engineering Certification (ASQ) or equivalent (preferred).
• Strong organizational skills, attention to detail, and ability to work independently.
• Excellent verbal communication and interpersonal skills.

If you are interested in this Sr. Staff Quality Engineer position, please apply to this posting with Luke Heuser at A-Line Staffing!