Quality System Cover Letter

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

Previously, I was responsible for liaison between the operations management and regulatory agencies (FDA, ISO, DOH) regarding audit findings, litigation, and complaints.

Please consider my qualifications and experience:

• Demonstrated computer skills in a variety of software especially the Microsoft Office package
• Proficient with Microsoft Windows, Word, Excel, PowerPoint
• BA, BS, BBA highly preferred, will consider combination of experience and education
• Lean/Six Sigma certification and -comprehensive technical knowledge of management system specifications and associated international standards
• Qualified auditor/assessor in standards for management systems / project management / organizational standards
• Systemic thinker with capacity to communicate, result oriented, speed in execution, openness and listening to others
• Experience in auditing practices and principles
• Experienced SME for FDA and other regulatory authority audits

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

In my previous role, I was responsible for education to staff regarding quality, ISO, regulatory requirements, and risk management issues.

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:

• Speak English and Swedish fluently
• Testing experience in mainframe and distributed system environments
• Demonstrated understanding of the testing role in Agile, Waterfall and Hybrid SDLCs
• Strong knowledge of cGMP and ISO 13485 quality system requirements
• Familiar with ISO 14971 and its application in quality processes
• Background in diagnostics
• IEC 62304/Software Design knowledge
• Effective implementation of quality systems in small companies

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

Previously, I was responsible for expert level knowledge and training in ISO 13485 and FDA Medical Device Compliance.

Please consider my experience and qualifications for this position:

• Proven success in the execution and application of quality systems, including the application of statistical principles, theories, and concepts
• Innovative development techniques and strategic thinking abilities
• Have in-depth knowledge of working with quality management systems in an IVD/Medical device environment
• Experienced in administration of software systems
• Experience within an Aerospace or Defence or high technology manufacturing organisation
• Experienced in using Q Pulse
• A valid Quality Management certificate
• Individual will work in several computer systems (Word, Excel, TipQA, MESci)

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

In my previous role, I was responsible for expertise on FDA Quality Systems regulations, and ISO 13485.monitoring).

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:

• Experienced leading audits, certified ISO17025 lead auditor preferred
• Project management development with experience in product compliance verification engineering, preferably for medical devices
• Experienced in reading, analyzing and interpreting quality project schedules, general business data, and solid knowledge of spreadsheets to make proactive project decisions
• Demonstrated success in LEAN improvement projects
• Be someone who works analytically and enjoy problem solving
• Have strong leadership and interpersonal skills, process and customer focused
• Drive cross-functional collaboration
• Be competent in process mapping

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

In my previous role, I was responsible for integrated Quality leadership and technical expertise to Phantom Works employees, suppliers, customers and regulatory agencies to ensure compliance with contractual, company, and regulatory requirements.

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

• Quality Related Certifications (ASQ, lead auditor)
• Excellent Skills with both Microsoft applications (Word, Excel, PPT, Vizio), and Salesforce.com-based platforms
• ASQ Certification for Quality Auditor preferred
• Proficient in quality management, operations, lean manufacturing processes and visual management
• Experience with Quality Management Systems in a manufacturing environment
• Intermediate level demonstrable Excel knowledge
• Quality Assurance experiences
• Able to work effectively in a collaborative team environment, across multiple functions