Development Quality Engineer Cover Letter

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

In my previous role, I was responsible for training to associates in FDA Title 21 CFR Part 820 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:

• Able to balance multiple projects in a fast paced environment
• An additional MSc component either as a part of a BSc or as an additional course is preferred
• Knowledge of best practice in Test
• Proven records of executing a Quality Plan, statistical sampling and participation in manufacturing quality analytics processes
• Strong Design, Development and problem solving skill
• Worked in any Database( SQL or NOSQL )
• Expert level experience in software development background including design patterns, data structures, test driven development
• Software development experience in any OOPS language and AWS infrastructure, building web services and highly scalable applications

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

Previously, I was responsible for expert knowledge of 21 CFR part 820 FDA requirements for Medical devices.

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:

• Support all Company initiatives as identified by management and in support of Quality Management
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements
• ETSI EN 302 195 (radio for EU)
• CISPR11 (also known as EN55011), or CISPR22 (known as EN55022)
• FCC part 15, part 95, and other ETSI wireless radio standards
• Basic knowledge of 21 CFR Part 820, ISO 14971 and ISO 13485
• Basic to Intermediate knowledge in Statistics, Design Control, Risk Assessments and Process Validation
• Understanding of Six Sigma and Process Excellence tools and methodologies

Please consider me for the development quality engineer opportunity. I am including my resume that lists my qualifications and experience.

Previously, I was responsible for expert knowledge of 21 CFR part 820 FDA requirements for Medical devices and ISO13485.

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

• Excellent verbal and written communication skil
• Expert level experience in object-oriented design and coding skills (C/C++ and/or Java on a UNIX or Linux platform)
• Statistical method and Critical to Quality training and experience
• Knowledge of professional software engineering practices & new standards for the full software development life cycle, including coding standards, code reviews, source control management, build processes, testing, and operations
• Experience in real-time analytical systems, machine learning and predictive models
• Competent is statistically analysis software packages (Minitab, JMP, Reliasoft, etc)
• Supports DHF content completion, integrity, and regulatory & standards compliance
• In-depth understanding of chemical structure characterization of inorganic organic materials

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

In the previous role, I was responsible for guidance for alignment with ISO13485 and FDA 21 CFR 820.

Please consider my qualifications and experience:

• Hands-on experience in chemical analysis using equipment such as SIMS/TOFSIMS, XPS, EDX/EELS, XRF, GC/MS, LC/MS, IC, TDS, UV-Vis, SEM-EDS, TEM and FTIR/Raman
• Competent is statistical analysis software packages (Minitab, JMP, Reliasoft, etc)
• Excellent verbal and written English communication skilss to work in a global team
• CMMI, A-Spice, ISO/IATF TS knowledge
• Leadership habilities
• Development (R&D) process experience (PDMK)
• Control plan and D/P FMEA experience
• Support objective component specification definitions, supplied component sampling plan development, and

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

In my previous role, I was responsible for quality guidance on GxP regulatory requirements (including but not limited to 21 CFR Parts 11, 820 and EU GMP Annex 11).

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:

• Experience in authoring Risk Assessments
• Proficiency with quality-related applications such as Minitab
• Basic to Intermediate knowledge and familiarity of MICROSOFT applications (Excel, Word and PowerPoint)
• Experience with user-level automation frameworks and scripting via Perl, Python,Java or JavaScript
• We also require strong analytical, writing, and interpersonal skills
• Electrical and/or software product knowledge is preferred
• Design control or new product development is preferred
• Quality engineering experience is highly preferred