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Judy Sullivan

@judysullivan

Detail-oriented quality engineer with expertise in regulatory compliance.

United States

What I'm looking for

I am looking for a role that offers opportunities for growth, collaboration, and the chance to make a meaningful impact in quality assurance.

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

CH

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.

ME

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.

CO

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.

TH

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.

TH

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.

UA

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 logoUP

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

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Judy Sullivan - Product Complaint Consultant - Judge Group-Moderna | Himalayas