Quality System Engineer Cover Letter

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

Previously, I was responsible for technical support during the NPI process in ensuring that from a Healthcare/Medical device perspective that all FDA, QSR, & MDD standards are achieved and maintained in respect to device.

Please consider my qualifications and experience:

• Strong organizational skills to track activities and communications
• BSC Experience preferred
• Lead / Support quality engineering activities to support production at the O”Hara Plant
• Assertive and highly technical multi-discipline engineer with an eye for continuous improvement of complex and large scale systems
• Experience with process controls is recommended
• Able to carry out root cause analysis for designs, field operation, and overall work processes
• Basic storage understanding - RAID, SANs, NFS, iSCSI
• Knowledge of Cloud architecture - eg

In response to your job posting for quality system engineer, I am including this letter and my resume for your review.

In the previous role, I was responsible for continuous re-enforcement and training of the respective requirements for medical device regulations and standards and J&J requirements to associates on site, including management.

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:

• Knowledge of laboratory and inline quality measurements and strong knowledge on statistical process control
• Skills in HACCP risk assessment and implementation
• Skills in auditing and facilitation
• Experience with testing consumer electronics
• Skilled in software quality assurance methodologies
• Familiar with embedded and mobile devices
• Previous working experience in an automotive company as a Quality Engineer, especially handling Germany automotive customers like VW, FORD is an advantage, knowing their basic requirement as well
• Experience in chemical, automotive or aerospace industries is preferred, ideally gained within a high tech manufacturing and product development environment

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

Previously, I was responsible for technical support during the NPI process in ensuring that from a Healthcare/Medical device perspective that all FDA, QSR, & MDD standards are achieved and maintained in respect to device classifications.

Please consider my experience and qualifications for this position:

• Strong background in developing and deploying effective Quality Management Systems
• Strong background in performing Quality Management System, process and product audits
• Strong background and working knowledge of ATEX, IECEx and FM compliance standards
• Experienced in the use of Microsoft Office to include Power Point and Excel
• ASQ Certifications in Quality Engineering, Six Sigma Black Belt or Auditing
• Detail-oriented and self-driving
• Solid skills in project and time management
• Exposure to Quality assurance processes and tools SIPOC, LEAN, FMEA, 8D, document control

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

Previously, I was responsible for guidance to project teams and business partners to ensure compliance with company policies and procedures as well as medical device regulations.

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:

• Proficient in information / data collection and analysis
• Knowledge of ISO 9001, IATF 16949 and other Quality Assurance industry standards
• Prior product or business process auditing experience
• English at a business level
• Working experience with ISO 13485 and with medical device regulations
• Experience in auditing techniques interpreting and transforming requirements to practical implementation
• ASQ or Industry Recognized Certification is preferred
• Posses technical competency in the Area of Food and Applied Microbiology

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

Previously, I was responsible for quality engineer support to ensure that products are manufactured with a high level of quality, while being in compliance with standards and regulations governing medical device manufacturing.

Please consider my qualifications and experience:

• Proven experience in using IT business systems
• Experience in using FMEA, new product development tools and basic statistics would be preferred
• Excellent coaching, facilitation and training skills
• Superior written and oral communication skills to independently prepare and deliver presentations, training materials and author procedures
• Support users to solve software issues such as missing data or incorrect data in SPC database, Suppliers COA upload failures, Customer CofA generation failures, CofA template changes
• Support software and hardware new installation or upgrades
• Knowledge on camLine software and OPC servers are preferred
• BSC Engineering or MSC Engineering or similar