Quality Systems Specialist Cover Letter

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

In my previous role, I was responsible for guidance on global compliance, such as CE Marking and product registrations, clinical evaluations in accordance with MDD Annex II and Annex VII and ISO 13485, Canadian CMDCAS, etc.

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:

• Duties are complex , through interaction of QS elements
• Quality systems and manufacturing experience
• Experience in contract manufacturing
• Comprehensive knowledge of Quality System standards and regulations including 21 CFR 803 & 820, including ISO 13485 / 14971
• Remain current in product knowledge and any changes and or upgrades to the complaint handling process and system
• Strong personal commitment to quality, patient safety and customer service
• Be able to interact with Health Care Workers, Consumers and other professionals regarding their Quality concerns
• Experience working in cross-functional or cross-divisional environments is preferred

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

In my previous role, I was responsible for leadership in implementing and maintaining to the latest ISO 14971 risk management to medical devices.

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

• Site audit prep activities
• Evaluate and recommend changes to current systems
• Understands root cause methodologies (fishbone diagram, DMAIC)
• Understanding of 21CFR 820, 806, 803, Part 11, Part 4
• Proficiency in MS Excel, MS Word, MS PowerPoint, MS Outlook
• Quality Systems Regulations experience
• Experience with Master Control as a Document Management tool is preferred
• AS9100C or Rev

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

In the previous role, I was responsible for guidance on global compliance, such as CE Marking and product registrations, clinical evaluations in accordance with MDD and MDR requirements, ISO 13485 and ISO 14155, China NMPA, Japan JPAL, compliance with FDA’s guidance documents, and including requirements that are relevant to the overall MITG/RGI priorities globally.

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:

• Regulated medical device industry experience
• Internal Auditor skill set/certification/experience
• Industry-level quality certification
• Strong analytical skill set with emphasis on statistical analysis, knowledge and application of quality engineering/process improvement tools and techniques, structured problem solving, PDCA, six sigma
• Demonstrate a high tolerance for ambiguity
• Strong awareness of technical standards basic to a medical device company
• Client-centric focus with strong relationship building skills
• Effective communication (oral presentations and technical writing) at all levels and across the organization

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

In the previous role, I was responsible for guidance to business unit on global compliance, such as CE Marking and product registrations, clinical evaluations in accordance with MDD Annex X, ISO 13485 and ISO 14155, compliance with FDA’s guidance documents etc.

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

• Adaptable, teachable, detail-oriented, multi-tasker
• Knowledge and experience with practical applications of risk based quality systems principles within the pharmaceutical industry
• Knowledge and practical application of project management practices and continuous improvement methodologies, including process mapping and evaluation, preferred
• Highly developed communication and interpersonal skills to influence, negotiate, resolve conflict and leverage alignment with key stakeholders at all levels organizationally internally and externally
• Lean Six Sigma certifications and/or training
• Strong knowledge of software validation
• Experience in executing validations of application systems
• Experience with business application implementation projects including being an active contributor on projects with deliverables per a project timeline

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

In my previous role, I was responsible for quality systems expertise toward the ongoing efforts for ISO 13485 Certification in Q2-2021.

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:

• Applies knowledge of aerospace design, systems and integration to perform failure and forensic analysis of aerospace components and systems
• Assesses impact or health of quality relative to the business system or value stream
• Interfaces with Company employees, suppliers, customers and regulatory agencies to ensure compliance with contractual, Company and regulatory requirements
• Experience in a complex, multinational work environment/company
• Pro Active, works independently, takes actions in the absence of specific instruction
• Excellent communication and advisory skills, result oriented.1700186946W
• OFDA 21CFR parts 820 and 11
• OISO 13485