Senior Engineer, Quality Cover Letter

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

In the previous role, I was responsible for gMP and process improvement guidance to Pharmaceutical Technology Management and other key stakeholders for processes governed by regulatory compliance requirements throughout the product development lifecycle.

Please consider my experience and qualifications for this position:

• Advanced skills with Microsoft Office suite including Outlook, PowerPoint, Excel, Word
• Requires travel including overnight and multi-day trips both domestically and internationally
• Training of Quality Technicians　　
• Exercise judgment within generally defined practices and policies in selection methods and techniques for obtaining solutions to problems with broad scope and complexity
• Previous experience in Quality customer complaints, root cause/failure investigations and using TrackWise for customer complaints, preferred
• Be able to interact with Health Care Workers, other medical professionals and consumers regarding their Quality concerns
• Proficient in Microsoft Office suite and statistical programs
• Green Belt or Black Belt certification is desirable

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

In the previous role, I was responsible for inputs to other areas of the company as required to implement customer and regulatory quality requirements.

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 working knowledge of production and process controls in a regulated industry
• Strong working knowledge of risk management for medical device products
• Working knowledge of supplier quality management
• Experience in root cause analysis, error proofing, and continuous improvement
• Experience in supplier quality and interfacing with suppliers in low cost countries
• Experience with preventive quality engineering techniques such as DFMEA, PFMEA, control plans, process mapping
• Good working knowledge of utilizing statistics for building analytic models
• A team player who can develop relationships, both internally and externally, to achieve the necessary engagement, influence and customer connections (both internal and external)

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

In the previous role, I was responsible for interpretation of regulatory guidelines and corporate requirements to ensure compliance and effective operation of the QMS.

Please consider my qualifications and experience:

• Experience in contract review, Quality Planning, failure analysis and corrective action
• Familiar with major Aerospace primes Quality System, working knowledge of AS9100
• Working knowledge of Six Sigma tools
• Detail-oriented personality and strong organizational skills
• Supervise technicians in the Product Analysis Lab
• Design for Six Sigma and Critical to Quality training and experience preferred
• Familiar with measurement/test equipment and statistical analysis methodologies
• Continuous improvement experience in a LEAN manufacturing environment is a definite asset, as is involvement with Kaizen and/or 5S projects or initiatives

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

In the previous role, I was responsible for governance to the team in the application of and compliance with engineering processes and practices, including engineering framework, LCM and regulatory requirements.

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

• Overall responsibility for production GMP standards and compliance, also including cleanroom
• Participate in new product introductions to ensure quality is built into all products early in their life cycle
• Support Production on all quality-related activities, including working closely with Engineering and other applicable functions
• Assist in the investigation and analysis of customer complaints and follow-up with the relevant functions to ensure that they are addressed & closed in a timely manner
• Assist in the definition of qualification/validation processes and the development of protocols in conjunction with appropriate functions
• Supervision and direction of other Quality personnel
• To support audits from external regulatory agencies (FDA, BSI) and customers and to lead preparation activities in advance of such audits
• Participates in Customer Complaints investigation for areas under their control and escalates critical issues as appropriate

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

In my previous role, I was responsible for quality oversight to ensure that validation and calibration are in accordance with quality and regulatory requirements.

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

• Understanding of ARP4754, ARP4761
• Hands-on experience with reading software requirements
• Experience working with outside software engineering suppliers
• Experience in Testing Web services - Testing experience in a Windows environment
• Experience with the creation and maintenance of automated test scripts in a fast-paced dynamic environment - Good spoken and written communication skills
• Experience with UI automation tools such as Microsoft Test Manager and Stress testing
• Hands on Experience in Testing and willingness to work as an Individual Contributor Role
• Strong programming knowledge in JAVA, HTML,XML, JavaScript, and CSS