Staff Engineer, Quality Cover Letter

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

In my previous role, I was responsible for expertise in the areas of Quality Assurance, Regulatory Compliance, Design Controls, Risk Management, and Statistical Analysis.

Please consider my experience and qualifications for this position:

• Experience with software verification and validation
• Experience with the application or risk management tools
• Understanding of software development, inspection, and testing
• Working knowledge of spreadsheets and word processor applications
• Experience with statistics, sampling plans, and statistical analysis
• Excellent knowledge of design controls and 21CFR820, ISO 13485, ISO 14971, ISO 10993, ISO 60601, IEC62304 and applicable medical device regulations
• Certified Quality Engineer and Certified Quality Auditor is preferred
• Have a track record of Quality improvements working with cross-functional, and cross-business teams

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

In the previous role, I was responsible for engineering support in the areas of Quality Assurance, Design Controls, Risk Management, and Statistical Techniques.

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

• Working knowledge of the SAP Quality module
• ISO/AS9100 or IATF16949 auditor
• Advanced Technical Training in Quality Engineering principles, Risk Management, Ophthalmic Sciences and Technology, Systems Engineering and/or Process Excellence (Certified Six Sigma Black Belt or master Black Belt) is preferred
• Capital equipment experience is preferred
• Execution and on-time completion of design control deliverables
• Prior medical device experience, or other regulated industry
• Proficient in Risk Management & Process Validation
• Proficient knowledge of Medical Device or pharmaceutical regulatory standards such as 21CFR820, ISO 13485, ISO 14971 and others relevant to Medical Devices

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

Previously, I was responsible for quality engineering expertise in the areas of Risk Management, Design Controls, Usability Engineering, Quality Assurance/Control, Regulatory Compliance, and Statistical Techniques, as needed.

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

• Extensive knowledge of applicable regulatory (such as 21 CFR Part 820, ISO 13485, ISO 14971, IEC 60601 and IEC 62304) Corporate and / or Unit requirements
• Familiarity with relevant Domestic and International Regulations and Industry Standards
• Strong knowledge of process control plans
• Previous experience working with plastics, resins, chemicals, mechanical parts, labels, foams, harnesses
• Provide Quality Oversight for the Manufacturing Execution System
• Experience with multi-site implementations of a Manufacturing Execution System
• Thorough knowledge of Quality and operations systems and processes, including GMP and QSR requirements
• Facilitate test failure/anomaly investigations and processing, MRB decisions, root cause analysis, and closed loop corrective action while identifying potential systemic causal relationships

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

Previously, I was responsible for expertise in the areas of Quality Assurance, Risk Management, Statistical Techniques, and Regulatory Compliance.

Please consider my experience and qualifications for this position:

• Lead quality topics such as 8D and FMEA especially on the assigned technologies or processes
• Drive risk assessment for process change, new process/ equipment release
• Prior experience and training in medical device quality systems is preferred
• Experience with LIMS software is preferred
• Analytical thinking with a logical step by step approach
• A good understanding of statistical analysis and techniques, practitioner of problem solving tools/methods (5whys, 8D, Is-Is not, correlation, flowcharting, Fishbone, Kaizen, PDCA, DMAIC)
• Expert knowledge of product development, and specifically software development (SDLC) processes, Software Engineering Best Practices Design Controls, Risk Management, Verification and Validation
• Comprehend software technical reports and specification documents

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

In the previous role, I was responsible for leadership in design in design & implementation of world-class quality engineering to support entire product life cycle with focus on quality engineering activities such as reliability, root cause/corrective action risk management, analytics/statistical techniques, requirements management, verification & validation, and design control across the lifecycle of the products.

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

• Individual should be a self-starter and be able to work independently
• Six Sigma (Green Belt, Black Belt, ) or Process Excellence certification is an asset
• Knowledge of Agile, SAP and/or ETQ is preferred
• Experience with electro-mechanical equipment is preferred
• Extensive knowledge and experience of applicable regulatory and FDA medical device requirements
• Experience working in medical device and/or pharma with CFDA, FDA and European regulatory environment is preferred
• Process Deployment and Continuous Improvement - Lead and drive innovative improvements to ensure global process deployment and effective implementation of Quality Control and Assurance practices
• Monitoring and Oversight - Lead development, deployment and oversight of metrics for Quality Control and Assurance to ensure appropriate monitoring of process compliance