Judy Sullivan
@judysullivan
Detail-oriented quality engineer with expertise in regulatory compliance.
What I'm looking for
I am a dedicated and detail-oriented quality engineer with over 15 years of experience in the medical device and pharmaceutical industries. My career has been marked by a commitment to excellence in quality assurance, where I have successfully developed and implemented quality assurance procedures to ensure regulatory compliance. I have a proven track record of conducting thorough root cause analyses and implementing corrective actions that enhance product quality and safety.
Throughout my career, I have excelled in roles such as Product Complaint Consultant and Site Principal Quality Engineer, where I collaborated with cross-functional teams to improve processes and ensure adherence to industry standards. My ability to analyze data, manage change control activities, and lead internal audits has consistently contributed to the success of the organizations I have worked with. I am passionate about cultivating client relationships and optimizing processes to achieve organizational goals.
Experience
Work history, roles, and key accomplishments
Product Complaint Consultant
Judge Group-Moderna
Aug 2021 - Mar 2024 (2 years 7 months)
As a Product Complaint Consultant, I reviewed policies and procedures, collaborated with Contract Manufacturers, and developed workflows. I performed investigations on product quality events and documented findings, ensuring compliance with regulatory standards.
Site Principal Quality Engineer
Cardinal Health
May 2018 - Aug 2021 (3 years 3 months)
In my role as Site Principal Quality Engineer, I conducted data analysis for quality issues, developed corrective actions, and maintained Quality Assurance procedures per ISO standards. I led internal audits and collaborated with teams to enhance product quality.
Senior Quality Engineer
Medtronic
Apr 2016 - May 2018 (2 years 1 month)
As a Senior Quality Engineer, I developed quality assurance procedures, conducted root cause analysis, and managed the Document Control Process. I ensured compliance with regulatory standards and improved product quality through auditing and feedback analysis.
Quality Engineer
Covidien
Aug 2011 - May 2016 (4 years 9 months)
In my position as Quality Engineer, I performed data analysis, investigated customer complaints, and conducted internal audits. I developed reports on product quality metrics and managed corrective actions to ensure compliance with quality standards.
Manufacturing Supervisor
Tyco Healthcare
Aug 2006 - May 2008 (1 year 9 months)
As a Manufacturing Supervisor, I ensured safety compliance, monitored production performance, and developed standard operating procedures. I supervised a team of over 30 employees and coordinated with various departments to enhance operational efficiency.
Process Engineering and Release Technician
Tyco Healthcare
Sep 1996 - Aug 2006 (9 years 11 months)
In my role as Process Engineering and Release Technician, I developed SOPs, troubleshot processes, and performed validation testing. I documented changes and participated in root cause analysis to ensure compliance with industry standards.
Signal Communications
US Army
Oct 1986 - Oct 1995 (9 years)
As a Signal Communications specialist in the US Army, I analyzed radio frequency data, developed training plans, and conducted classroom instruction. I enforced safety standards and assessed soldier readiness for deployment.
Education
Degrees, certifications, and relevant coursework
University of Phoenix
Bachelor of Science, Management Science
2006 - 2010
Completed a Bachelor of Science in Management Science, focusing on the principles of management and their application in various organizational contexts.
Tech stack
Software and tools used professionally
Availability
Location
Authorized to work in
Job categories
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