Supplier Quality Engineering Cover Letter

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

In my previous role, I was responsible for support in completing SFMD quality deliverables and collaborate with cross-functional new product development teams to onboard finished medical device suppliers.

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:

• Experienced with International Component Suppliers / Manufacturing
• Knowledge of medical device regulations, standards, guidelines, directives, global and domestic standards as applicable
• Proficiency on various applications such as MS and other statistical tools JMP, Minitab
• Highly motivated and able to build close relationships internally and externally
• The individual should enjoy working in a dynamic and results oriented team environment focusing on quality, compliance and customer satisfaction
• Experience in manufacturing, operations, design, quality assurance or regulatory assurance
• Work with cross functional team to resolve supplier production quality issues in a timely, systematic fashion
• Identify supplier related problems & opportunities

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

In the previous role, I was responsible for supplier Quality Engineering leadership in direct support of medical device manufacturing, including:.

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

• Coordinate with manufacturing, product design, procurement and supplier quality engineering teams on component delivery/ quality issues and supplier improvement initiatives
• Provide technical leadership, support and guidance to Supplier Development Engineers
• Lean Six-sigma quality process knowledge
• Well verse with statistical quality control methodologies and tools
• Good understanding of component manufacturing process with extensive quality management experience of categories such as textile, power supply, PCBA or battery assembly
• Basic knowledge with GMP, ISO 13485, 21 CFR Part 820 standards
• Basic knowledge of FMEA, Validation Programs and SPC processes in a highly regulated environment desirable
• Highly motivated and able to build relationships internally and externally

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

In the previous role, I was responsible for subject matter expertise (SME) in interpretation of ISO9001, ISO13485, FDA 21CFR Part 820, SFDA, Japanese MHLW , ANVISA and other standards (domestic or international) relevant to the medical sector.

Please consider my experience and qualifications for this position:

• Maintain lessons learned from various investigations to assist in development and sharing of best practice
• Problem solving methods & tools quality process knowledge, including statistics (A3, 8D, KT Problem Solving, DMAIC )
• Strong communication skills & business acumen
• Supplier manufacturing process knowledge and understanding of various manufacturing processes such as electronic assembly
• Experience in engineering processes and tools in manufacturing environments
• Incoming Inspection for mechanical and electrical parts
• CMM instrumentation selection, verification, programming
• Nonconforming part processing and MRB support

I submit this application to express my sincere interest in the supplier quality engineering position.

In my previous role, I was responsible for device Quality support to Device Technical Leads of above-site / multi-site Combination Products and Medical Devices in support of device compliance maintenance activities (e.g Design History File, Device Master Records 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:

• Supplier Quality support (defect trending, supplier trending, audits)
• Product Service Report review and trending
• Quality document updates including inspection plans, drawing reviews, procedure changes, MRB reports
• A minimum of an BTEC HNC/HND in Engineering or similar field is preferred
• CQI Certification Preferred (CQE, CQA, CMQOE)
• Develop collaborative working relationships with suppliers to properly identify and mitigate potential production and/or manufacturing constraints for an on-time delivery of purchased components
• Influence supplier direction toward optimal process design and problem-solving path, using leadership skills and data-driven proposals
• Work with global supplier alliance teams, suppliers and product design teams to promote the smooth introduction of changes to existing products and processes, whilst seeking opportunities to improve the overall value of the supply activities

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

Previously, I was responsible for input into medical device and future device iterations – develop concepts and requirements documents.

Please consider my experience and qualifications for this position:

• Lead and develop a team of supplier quality professionals to drive the highest supplier quality standards for all new and existing products
• Manage the Supplier Corrective and Preventive Action (SCAR) program to ensure suppliers meet performance requirements in quality and service throughout the product life-cycle
• Support sustaining engineering efforts which impact purchased parts and services to assure quality meets current or revised standards and interact with various New Product Development Project teams
• Influence supply base to implement best practices and continuous improvement initiatives to achieve a world class performance in quality
• Experience with various manufacturing processes/commodities such as electro-mechanical assemblies, plastic injection molding, printed circuit assemblies and contract manufacturing
• Quality Systems auditing experience to a standard
• Aware of or trained on Cell Operating System
• Experience with MES Systems (e.g., JDE, SAP, Factory Works) and Data Collection Systems (e.g., SAP QM, SPACE/SPICE/SQM)