Design Quality Engineer Cover Letter

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

In my previous role, I was responsible for design assurance support in the design and development of medical device products, facilitating the application of design/change controls, risk management, and implementation of design and development plan.

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:

• Facilitating and managing Design and Process FMEAs/FMECAs in a research and development setting for the Surgeon User Interface and potentially other subsystems within the Minimally Invasive Surgical System
• Providing guidance and oversight of the plans and methods for subsystem verification
• Providing guidance on the principles of electrical engineering and IEC standards as they relate to the new product development activities of electromechanical medical devices
• Participating in engineering Design Reviews
• Participating in Defect / Issue Management and Change Control Boards, as appropriate
• Managing the Risk Management Process per ISO 14971 at a subsystem level
• Qualifying production components through Covidien’s Production Part Approval Process (PPAP)
• Developing Quality inspection procedures, including sampling plans, for both production level components and finished devices

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

In my previous role, I was responsible for leadership in all areas of the Quality System, including but not limited to design controls, risk management, etc.

Please consider my experience and qualifications for this position:

• ORisk analysis
• OHighly proficient in math and use of statistical techniques
• OSix sigma
• ODesign of experiments
• OLean principles
• ORoot cause analysis
• OProblem solving approaches
• Experience with electromechanical device development preferred

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

In my previous role, I was responsible for support in the design and development of medical device products and facilitate the application of design controls and risk management.

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

• Initiating corrective action requests on non-conformances (internal or external) and verifying the effectiveness of corrective actions
• Ensuring all FDA and ISO validation requirements are met and for the review and approval of all validation protocols (IQ, OQ, PQ and MSA)
• Strong problem solving skills with an emphasis on processes
• Intermediate project management skills/knowledge
• Proficiency in CAD modeling skills (preferably Unigraphics, or SolidWorks)
• Proficiency in Windows Excel, Word, Project and PowerPoint
• Experience and knowledge of SAP or similar ERP system
• Experience working within a manufacturing company preferred

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

Previously, I was responsible for design assurance support in the design and development of medical device products and facilitate the application of design controls and risk 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:

• Formal Six Sigma training/certifications preferred
• Understanding of current Quality techniques, industry standards
• Actively represent Quality Assurance function on product/process project teams
• Strong embedded systems knowledge
• Willingness to travel (quarterly once, 1-2 weeks abroad)
• Knowledge of design controls and 21CFR820, ISO 9001, ISO 13485, ISO 14971, ISO 10993 and applicable Medical Device regulations
• Proficiency in risk management tools
• MS Office suite IT packages would be ideal proficiency in Excel and Powerpoint

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

Previously, I was responsible for guidance and direction in the areas of Design Controls, Risk Management and Design Transfer to cross functional teams.

Please consider my qualifications and experience:

• Demonstrated technical leadership in airframe detail part, tool design, and fabrication
• Knowledge and practical application of ASME Y14.5 and Y14.100 requirements is preferred
• Experience with Sikorsky design guidelines, Design and Drafting Manuals, Standard Work
• Evaluation and validation of product and process test methods
• Provides input to design and manufacturing drawings, inspection procedures, and manufacturing procedures to ensure that the resulting products can be adequately manufactured and tested
• Quality Engineering/Design or Process Excellence/Lean experience is preferred
• Problem solving techniques including root cause analysis and cause and effect analysis are all preferred
• Experience working with New Product Introduction (NPI) and solid knowledge working with design control and risk assessment