Senior Quality Specialist Cover Letter

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

Previously, I was responsible for support to any area that requires help to implement Regulatory and Quality Management Systems requirements into their processes.

Please consider my qualifications and experience:

• Experience in SAP, Trackwise are strongly preferred
• Able to apply quality risk management effectively
• Committed to quality and maintains a high standard of work at all times and demonstrates the highest levels of integrity and a strong work ethic
• Good interpersonal skills and able to work with cross functional team collaboratively
• Triage, evaluate and process product quality complaints
• Review complaint case to verify customer verbatim, lot number, subject coding, trend analysis, malfunction coding, and complaint closure as applicable, and escalate, as needed
• Perform follow-up activities to gain additional information as needed
• Manage and track communication with customers, hospitals, sales representatives

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

In my previous role, I was responsible for support to the operational processes, to ensure the implementation of all Quality standards and procedures and to ensure that processes are executed per Corporate and Regulatory requirements.

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

• Good knowledge of UI Automation Framework and different Automation tools(Selenium/UFT)
• Knowledge on API testing tools will be an added advantage
• Solid experience with Linux/Unix environments
• Solid experience with Agile software development and TDD
• Experience with distributed Source Control Management (e.g., Git, Mercurial)
• Experience with Maven, Gradle or similar
• Knowledge and experience with dev ops general concepts and tools, infrastructure as code using Chef, Puppet, Ansible
• Experience testing services running in a cloud environment (e.g., AWS, Heroku, Azure)

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

Previously, I was responsible for leadership and oversight for HealthPartners Laboratories patient safety, quality improvement, and regulatory and accreditation operations, including accreditation and certification programs.

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 with Failure Mode Effects and Analysis is preferred
• Understanding of testing mobile applications
• Comfortable in Agile fast paced environment
• HND or BSc in a Biological subject
• Experience in audit involvement
• Proven IT skills
• Supported the development of DHF (design history file) deliverables for medical devices
• Extensive knowledge of applicable medical device regulations (21CFR820, MDD, ISO 13485)

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

In my previous role, I was responsible for documented certification results for Unix security solutions that demonstrate they meet the requirements of applicable use cases.

Please consider my experience and qualifications for this position:

• Solid financial accounting and internal control knowledge
• Experience in leading business process transition and SAP deployment are strong advantage
• Six Sigma certification (Green Belt or Black Belt) is preferred to engage in QA role
• People management and leadership experience is strong advantage
• Flexible and willingness to learn
• Structured approach to effectively and efficiently plan workload
• Have experience of 8D investigation methods and product validation
• Have experience in terms of containment and be able to provide regular updates to internal stakeholders

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

Previously, I was responsible for quality review and approval for analytical validation activities so that these activities meet the required standards appropriate for the activity and phase of development.

Please consider my experience and qualifications for this position:

• Attention to detail - Thoroughly check all aspects of work for accuracy, completeness and compliance
• Strong, working knowledge of cGMPs, document management, collection and archival
• Experience with managing document flow during Board of Health (BOH) Inspections
• Advanced understanding of FDA regulations/guidance
• Experience with Documentum, SAP and other database systems
• Experience in NC and CAPA, root cause investigations and determinations of appropriate corrective and preventative actions
• Experience analyzing data for trend identification and/or process improvement opportunities is strongly preferred
• Able to read, analyze, and interpret technical documents is preferred