Senior Design Quality Engineer Cover Letter

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

Previously, I was responsible for consultation to design and process owners with regards to design verification and design validation protocols and reports.

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 medical device regulations (FDA 21CFR80.820, ISO13485, ISO10993)
• Mastery of software programs - Microsoft Excel, PowerPoint, and Word
• Design Controls / CAPA / Purchasing Controls
• Risk analysis (ICH Q9 and/or ISO 14971)
• Medical Device & Combination Product regulations (ISO 13485/11608, IEC 62304, 21CRF part 820, 210/211)
• Be an effective communicator and working knowledge of device development and commercialization, product approval, and/or regulatory inspection experience with the medical device constituent of a combination product
• Technical expert working independently, and have excellent interpersonal relationship skills with flexibility to adapt to fast pace environment with changing priorities
• Experience in the use of root cause analysis and applied statistical techniques

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

In the previous role, I was responsible for quality leadership to new product development teams, with focus on reagent and assay development, in the areas of design control, design verification and validation, design transfer, process validation, risk management, and specification development.

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:

• Review and approve documentation consistent with design control regulations and guidance’s dealing with systems/software development, verification and validation practices and GPS design control policy and SOPs
• Author and, or review/approve Quality Plan and Report at milestones DI, DO and LD
• Previous design verification/validation experience, and use of statistics preferred
• Knowledge of Good Manufacturing Practices (GMPs), Quality System standards and regulatory requirements such as 21 CFR 820, CFR 809 (IVDD), ISO 13485
• Holds a professional / academic scientific qualification B.Sc
• Experience in a similar Product Development Engineering role or Quality/ Compliance/ Regulatory related role in relation to product development within a Medical Devices or other highly regulated industry
• Knowledge of Medical Device Quality Systems standards and specifically Design Control according to 21CFR820 and ISO 13485, and Risk Management for medical devices in accordance with ISO14971 preferred
• Demonstrates excellent knowledge of statistical sampling and analysis tools/methods to support data-driven decision making

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

Previously, I was responsible for quality leadership to in the areas of design control, design verification and validation, design transfer, process validation, risk management, and specification development.

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

• Apply knowledge of Design Control principles and quality engineering techniques to positively influence new product development efforts, including those for design verification, validation, specification development, and risk management
• Hands on participant in early stages of product development including but not limited to physician interaction, component engineering, competitive product and prototype testing
• Identifies quality characteristics and validation criteria for components, subassemblies, and finished devices
• Experience with vascular devices, embolic coils, stents, and/or catheters, preferred
• Strong working knowledge of quality systems and quality assurance processes and principles, with a focus on software development and verification/validation activities
• Makes decisions and proposes solutions based on calculated risks identified through data analysis
• Ensures all tasks are conducted in accordance with Quality Systems procedures
• Assist with training Quality Engineers and cross-functional team members in quality processes and disciplines

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

In my previous role, I was responsible for support to Operations teams to ensure successful transfer of the design and design controls to manufacturing.

Please consider my qualifications and experience:

• Fundamental understanding of software development process for medical devices including Software Verification and Validation
• Working knowledge of quality systems and quality assurance processes and principles, with a focus on software development and verification/validation activities
• Understanding of common software evaluation methods such as Code review, static analysis, state machine testing, Software FMEA
• Understanding of common software development approaches – Agile
• High level working knowledge of data analysis - comfortable with application of the 7 basic quality tools and typical statistical tools for Quality - SPC, sample size evaluation, DoE
• Experience working with product development - should understand concept and typical implementations of V model for development
• Understanding of requirements vs
• Provide design control and software/systems development guidance to Personalized Health Care software development teams and life cycle teams and be the single point representative for Design Quality Assurance activities on PHC software development project teams

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

In the previous role, I was responsible for quality leadership to new product development teams, with focus on sequencing instrument and consumable development, in the areas of design control, design verification and validation, design transfer, process validation, risk management, and specification development.

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 with the MS Office Suite, and statistical software
• Master TS Core tools such as PFMEA, DFMEA, Control plan…
• Understanding of electronics assembly processes (reflow, wave soldering, Select wave)
• Experience or knowledge in electronic components, including printed circuit board, passive components, interconnects and semiconductor devices (discrete and integrated circuits)
• Willingness to work in a lab environment with hands-on work on solder joints and theoretic prediction
• Advanced Technical Training in Quality Engineering principle, Risk Management, Product Testing, and Sports Medicine is preferred
• Certified Quality Technician (CQT), Certified Quality Engineer (CQE), Certified Quality Auditor (CQA) Certification or equivalent experience
• Fluency in Minitab Statistical Software and the presentation of complex quantitative data