Senior Quality Systems Engineer Cover Letter

I submit this application to express my sincere interest in the senior quality systems engineer position.

In the previous role, I was responsible for training to the organization on QSR requirements, ISO 13485.

Please consider my experience and qualifications for this position:

• Require sound knowledge of Rail Systems Quality Assurance and Quality Control principles, methods and practices and comprehensive knowledge of test methods and documentation
• Demonstrated technical leadership and management experience
• Possess sound judgement
• Strong computer skills, including Word, Excel, PowerPoint, Outlook, and Visio
• Excellent communication and relationship management skills in order to quickly build credibility within the Quality and Compliance community, partner with executive management and external regulators
• Formal training in Lean/Six Sigma, AS9100 preferred
• Quality engineering or management experience working in the DoD or aerospace industries is preferred
• Manufacturing or Quality Engineering experience desirable

I would like to submit my application for the senior quality systems engineer opening. Please accept this letter and the attached resume.

In the previous role, I was responsible for guidance on interpretation and application of specified QA/GMP compliance regulations, e.g., 21 CFR Part 11/210/211.

My experience is an excellent fit for the list of requirements in this job:

• Experience with working on Agile/Scrum teams
• Experience in working in Container and/or other microservices environments
• First-hand knowledge of applicable US (21 CFR 820) and EU (ISO 13485) quality system requirements with experience in IVDR/MDR and MDSAP
• Corrective and Preventive Action programs and Root cause analysis
• Expertise knowledge level and application of QSR’s, MDR/IVDR, IVDD, EU/ISO 13485, 14971, and MDSAP
• ASQ CQE/CSQE or equivalent
• Supplier assessment and approval through site audits
• CATSWeb or CAPA database applications

I am excited to be applying for the position of senior quality systems engineer. Please accept this letter and the attached resume as my interest in this position.

In my previous role, I was responsible for guidance in interpretation and correct application of 21 CFR Part 11 regulation in new and existing systems.

Please consider my qualifications and experience:

• Flexibility to adapt to change is essential
• Experience with EtQ Instinct CAPA module or similar platforms such as Trackwise is preferred
• A certification in Process Excellence
• Experience with front and back room is strongly preferred
• Certified lead auditor, with significant audit experience
• Experienced in regulatory audit preparation and participation
• Thorough knowledge and experience with FDA/GMP/QSR and ISO 13485
• Knowledge of risk management (FMEAs), process validation, statistical process control, and statistical sampling plans is desirable

I submit this application to express my sincere interest in the senior quality systems engineer position.

Previously, I was responsible for leadership in the understanding of the QSR and ISO 13485 regulations both within Quality and to other disciplines and help represent Quality during Third Party audits.

I reviewed the requirements of the job opening and I believe my candidacy is an excellent fit for this position. Some of the key requirements that I have extensive experience with include:

• Defining and automating end-to-end test cases and incorporating use case scenarios that will help on continuous deployment
• Debugging and defining issues based on end-to-end testing
• Scale and performance tests
• Installing, configuring and maintaining automated testing framework
• Strong Automation background
• Strong Linux background (system level)
• Good communication and organizational skills and experience working in team environments
• Experience with TFS or GIT and other development automated build and code repository frameworks

I submit this application to express my sincere interest in the senior quality systems engineer position.

In my previous role, I was responsible for guidance to the business on QSR/ISO requirements.

My experience is an excellent fit for the list of requirements in this job:

• Previous work in a similar role interfacing with or from a contract firm
• Global and regional enterprise-wide electronic systems involved in GMP activities
• Ensure adherence to and continuous improvement of the System Development Life Cycle processes
• Provide day-to-day guidance and support to the computer systems validation team and interfacing with Program Managers and other team leaders
• Experience with auditing Software Quality Management Systems
• Experience with leading successful teams, maintaining schedules, dealing with resource constraints, providing guidance, and with identifying and recommending changes to established practices
• Design, implement and manage software automated testing strategy and harnesses from inception
• Work with developers to identify, track and fix bugs