Senior Quality Manager Cover Letter

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

Previously, I was responsible for ongoing support and maintenance for existing quality systems (Integrated Document Control System-IDOX; Mfg Data-MFGD; ISO Form Control-ISOFORMS; Quality Specification System-QSPECS; Quality Management System-QMS; Uptime Data Collection & Reporting-UPTIME.

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

• Demonstrated experience in managing within a regulated environment 21CFR, ISO 13485 / 9001 and 17025
• Knowledge of Quality Assurance and Quality Control requirements/applications
• Proficient in Microsoft Outlook, Word, Power Point, Visio and Excel
• Certified Green belts with Banking background
• Proven experience in driving continuous improvements across teams using Lean Six Sigma framework
• Facilitative Leadership skills – Influencing skills, mentoring and coaching – to be able to drive change
• Experienced with Plastic Mold Injection operations is ideal
• Working knowledge of GMP (Good Manufacturing Practices - preferably medical device), ISO (International Organization for Standardization) & MDD (Medical Devices Directive) requirements is preferred

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

In my previous role, I was responsible for for supplier quality, process quality, finished goods and quality systems consistent with the ISO 9000 prevention model, and specifications of the commercialized product customer requirements.

Please consider my experience and qualifications for this position:

• Good knowledge and application of GMP
• Proven managerial / supervisory experience preferred
• Able to see the big picture, versatile, meticulous, self-motivated, able to work under pressure
• Exhibits good leader behaviors and interpersonal skills
• Direct experience of GMP audit management within the pharmaceutical industry is essential, and will include exposure to FDA, EMA or other authorities of similar standing
• High level technical skills including quality risk management, auditing and pharmaceutical manufacturing and regulatory inspection management
• Excellent knowledge of NYC building code national codes and various applicable design standards
• Knowledge of NYC market to be able to provide adequate and competitive pricing for new opportunities

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

In my previous role, I was responsible for support for process improvement exercises in support of local ISO Quality Management System (QMS) optimization initiatives.

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

• Good working knowledge of quality management systems and ISO standards
• Strong focus attention to details
• A strong commitment to quality and patient safety
• A good understanding of internal customer needs and project needs
• Leading contact with manufacturing, R&D, procurement, and suppliers to resolve raw material quality and food safety issues
• Providing technical guidance, developing and upgrading specifications and approving suppliers for new and current ingredients
• Driving simplification and harmonization in our ingredient portfolio supply base
• Leading continuous improvement initiatives and enhancements to the cost/quality relationship of suppliers such as participation on global strategic sourcing teams and Value stream mapping activities

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

In the previous role, I was responsible for support to the Quality Function including implementing quality control and assurance activities at every stage of business process and reinforce the project quality management system to ensure quality of product, enabling continuous improvement of quality and prevention of quality-related problems.

Please consider my experience and qualifications for this position:

• Should be open to traveling to multiple client locations up to 3 months duration for short
• Term or 12 months for long term assignments
• Assigns and reviews project work of staff, sets work priorities, and reviews work
• Prepares overall project quality plans including milestones, validation processes and documentation procedures
• Hires and retains a diverse, highly qualified staff and provides coaching and ongoing performance feedback
• ESD control
• Program contractual requirements and flow down to suppliers/sub-contractors
• Configuration management and change management procedures

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

In the previous role, I was responsible for oversight for the development and maintenance of quality programs, systems, processes and procedures especially in the areas of production and process controls, management of non-conforming product, and continuous improvement and change control.

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:

• Fluent written and spoken English with level 6 minimum
• Ethics and integrity in dealing with suppliers
• A Certified Quality Auditor (CQA) or similar certification is highly desirable
• Demonstrated knowledge and understanding of applicable FDA regulations and international standards and provides strategic direction to site leadership and functions in terms of ensuring a suitable and effective quality management system is present
• Demonstrated knowledge and experience of a wide range of medical devices such as interventional cardiology products and/or systems hardware
• Able to work independently, make compliance decisions and direct other resources on compliance decisions related to complaint handling and safety reporting activities
• Have entrepreneurship
• Solid understanding of quality processes, methods, and tools (APQP/PPAP, PIQ, A3, 8D, DFMEA/PFMEA, QFD, DVP&R, Control Plan)