Quality Management Systems Cover Letter

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

In my previous role, I was responsible for expertise for quality and quality management systems requirements associated with federal government regulations.

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 at managing programs and influencing stakeholders at all levels
• Skill in multiple computer based tools and software programs such as Word, PowerPoint, Excel, Visio, MS Project or site builder
• Deep understanding of Quality Systems Regulations
• Knowledge of quality system regulations and the application of regulations within quality systems
• Experience at developing project schedules
• Experience in a regulated industry and complying with Quality Systems, preferably medical device, pharmaceutical, biologics or aerospace
• Extensive knowledge of major Flexibles raw materials such as resins, foil, plastic films, adhesives and inks, and their manufacturing process
• Extensive knowledge of Flexibles manufacturing processes such as extrusion, lamination, printing and converting

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

In my previous role, I was responsible for documentation support for internal, regulatory or Corporate audits to ensure compliance with domestic and international regulations, quality requirements and guidance documents.

Please consider my experience and qualifications for this position:

• Experience leading projects in a highly regulated environment
• Experience with continuous improvement tools and processes
• Experience leading a large scale quality systems deployment project
• Experience applying Lean and/or Six Sigma methodologies to pharmaceutical facilities and manufacturing processes
• Strong working knowledge of cGMPs
• Strong Leadership Skills including but not limited to strong team work collaboration, transparent communication, integrity, change agent, developing people, leading by example
• Strong Microsoft office skill level including Visio, Word, and Powerpoint
• Travel and flexibility

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

In my previous role, I was responsible for the strategic plan and roadmap to create a robust quality management system; including ISO :9001 and :13485.

Please consider my qualifications and experience:

• Experience with staffing issues such as interviewing potential staff, conducting appraisals and performance reviews, providing or organizing training and development
• Preferred pursing a BS/ BA in Business, Marketing, Human Resources, Educational Learning, Quality Assurance, or Regulatory Affairs
• Strong Attention to detail, with supurb time management and organizational skills
• Internet explorer and web based systems
• E-learning, LMS, SharePoint, Objective
• Maintain an outstanding work ethic and an enthusiastic approach to getting the job done
• Possess confidence to directly communicate and resolve issues amicably with manager and co-workers
• Provide continuous improvement support to the site QSIP deployment team

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

In my previous role, I was responsible for support to the Corporate Supplier Audit program by conducting audits of suppliers for compliance with ISO standards, local regulations, material specifications and internal requirements.

Please consider my experience and qualifications for this position:

• Provide project management support to the site QSIP deployment team
• Provide suggestions to site SMEs on process improvement ideas
• Cultivate and foster a positive working relationship within teams, and with employees and other stakeholders to gain cooperation, support, and buy in to continuous improvement
• Plan, coordinate, schedule, organize, and facilitate various process improvements including, but not limited to training, workshops, rapid improvement events, process mapping
• Support facilitation of analysis and improvement events
• Guide Subject Matter Experts on revising procedures, processes, and/or methods to increase effectiveness, test alternatives approaches, assist in the installation of approved improvements/modifications, provide instruction to operating personnel, and perform follow up to ensure defined outcomes are achieved
• Document and manage project timelines, resources, and visual performance boards
• Cultivate collaborative relationships with stakeholders within all organizational levels, building trust and gaining credibility to achieve optimal value

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

In my previous role, I was responsible for quality Systems support and ongoing program development for Global Quality Management System (GQMS) and Quality Document Management System (QDMS).

Please consider my experience and qualifications for this position:

• Knowledge of Quality Management methods bases on norms and standards DIN ISO, APQP, FMEA, IP, SPC
• Certified auditor for TS/IATF 16949, ISO14001 preferred
• Spanish and/or German an asset
• Certified Lead Auditor IAW AS9100 Rev
• Proven track record of effectively communicating information at all levels of the organization
• Experience in managing mid to large projects in a cross-functional global environment
• Will Interact with and influences across multiple departments and sites
• Shall lead Global Site Lead team and drives performance and results