Quality Director Cover Letter

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

In my previous role, I was responsible for support for the ISO-14001, OHSAS-18001, and ISO-50001 programs.

Please consider my qualifications and experience:

• ASQ certified Quality Auditor (CQA), Quality Engineer (CQE) or Quality Manager (CQM) is preferred
• Significant experience with quality systems in an IVD/Medical device environment
• Willingness to travel in order to accomplish assigned goals
• Broad business perspective
• Experience in leading in a matrix environment
• Talent Management skills to include interviewing and coaching
• Teaming and team building skills
• Working knowledge of Quality System Regulation (QSR 21 CFR 820), Canadian Medical Device Regulation (CMDR SOR/98-282), EU Medical Device Directive (EU MDD 93/42 EEC), and ISO 13485, JPAL and other applicable standards

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

In my previous role, I was responsible for the tools and processes necessary to the engineering team to meet the requirements and fulfill the responsibilities specified in the company's ISO processes.

Please consider my experience and qualifications for this position:

• Prior experience establishing or managing change control and document control systems
• Prior experience establishing or managing a corrective action system
• Prior experience establishing and analyzing metrics to measure QMS effectiveness
• Problem Solving concepts (8D, A3, Root Cause Analysis )
• ISO9001/ISO Standards knowledge auditing knowledge
• Excellent knowledge of statistical analyses, DOE, measurement system analysis
• A proven track record of performing at a high level in Regulatory Agency Inspections as a subject matter expert
• Japanese Pharmaceutical Affairs Law (JPAL) certification is preferred

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

In my previous role, I was responsible for support in all areas related to ISO 9001 and ISO 14001 certifications.

Please consider my experience and qualifications for this position:

• Microbiology concepts, protocols and sterilization
• Medical device industry and market knowledge
• Analytical, financial and budgeting skills
• Experience using Six Sigma tools to resolve issues
• Experience influencing internal/external customer relationships
• History of effective project management for multiple and complex technical projects
• Strong managerial behaviors as evidenced through the management and development of direct reports
• Technical background with knowledge in garment construction

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

Previously, I was responsible for support to Quality Assurance & Control for ISO 9001 and ECM audit activities and related preventive/corrective actions follow up.

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:

• Strong mathematics and statistics skills and related tools
• Experience in communications with internal/external executives
• Working knowledge of ISO 9001 compliant quality management systems
• Prior experience in a regulated environment, such as automotive, aerospace, or medical device
• Trained/Certified in Lean
• ASQ manager or engineer certification
• Prior experience establishing a supplier quality process
• Prior experience establishing a quality management system in a startup environment

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

In my previous role, I was responsible for internal auditing of plant wide procedures and processing to ensure our systems meet HPS requirements along with the ISO Standard.

Please consider my experience and qualifications for this position:

• Problem solving skills and good statistical and analytical skills are necessary
• Proven Management and leadership skills are essential
• Japanese and or Standard Chinese preferred
• Expert knowledge of cGMP requirements and current Health Authority
• Is knowledgeable to execute quality systems including risk management, investigations, change control and CAPA
• Cross Segment/Global working knowledge
• Deployment Strong Implementation & pull through
• Business Related and Solutions Oriented