Staff Supplier Quality Engineer Cover Letter

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

Previously, I was responsible for leadership & support to J&J process excellence initiatives including Six-Sigma, design excellence & lean thinking.

Please consider my experience and qualifications for this position:

• Participate in local site supplier quality meetings to ensure communication and alignment of quality initiatives
• Perform and Support supplier/ EM quality evaluations and/or audits
• Develop quality agreements, and other quality related activities impacting supplier
• Strong statistical skills are preferred
• Experience or knowledge with machining, chemical manufacturing processes and injection molding an asset
• Six Sigma, Lean or ASQ CQE Certification and trainings an asset
• Experience with Quality Audits is preferred
• Auditor certification from an industry recognized organization is preferred

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

In my previous role, I was responsible for direction in implementing Incoming Inspection Plans, First Article Inspection, In-Process and Final Product Inspection, Sampling Plans, inspection and test acceptance criteria, and resolves nonconformances.

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:

• Require working knowledge of Word, Power Point and Excel with competency in moderately complex functions for data analysis and trending
• Proven track record of project implementation and planning
• Expertise is cross-functional projects with a global team
• Expert in statistical techniques
• Expert in manufacturing implementation – MVP, IQ/OQ/PQ, DOE, Gage RR, pFMEA, Controls Plans, Inspection Plans
• Six Sigma training and experience, or equivalent
• Skilled at cross-functional communication to a global audience, often outside of the quality department
• Expert in ISO 9001 requirements

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

In the previous role, I was responsible for technical assistance, as required, to Design Groups and QA/QC concerning applications of probability statistics, design of experiments, test planning and sampling plans.

Please consider my qualifications and experience:

• Good organizational and presentation skills are preferred
• Works well in a team-oriented, cross-functional environment is preferred
• Experience with managing supplier quality in the production of plastic molding and metal forming processes
• Experience setup or maintenance of 3rd party contract manufacturers
• Direct experience with supplier producing parts in a regulatory environment
• Competent in Process Audit, CAPA, PPAP, Equipment Validation
• TS16494 / ISO9001 or ISO 13485
• Experience or knowledge with machining, chemical manufacturing processes and injection molding is an asset

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

In the previous role, I was responsible for quality support to Manufacturing Engineering with sampling plans, data processing or analysis for validation for new and existing product lines.

Please consider my qualifications and experience:

• Six Sigma, Lean or ASQ CQE Certification and trainings are preferred
• Understands specification drawings and departmental procedures
• ASQ certified in Quality Engineering is preferred
• Quality engineering experience in new product development, technical manufacturing sustaining support, and process validation is preferred
• Thorough understanding of risk management principles and techniques
• Strong understanding of Manufacturing processes like Injection Molding, Extrusion, Machine Shops
• Strong communication, partnerships, and problem-solving skills
• Demonstrates a basic understanding of the Medical Device Quality Systems, emphases on purchasing controls

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

In the previous role, I was responsible for direction to suppliers in implementing Incoming Inspection Plans, First Article Inspection, In-Process and Final Product Inspection, FMEAs, Sampling Plans, inspection and test acceptance criteria, and handling non-conformances/CAPA.

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

• Working experience with Medical Device-associated materials such as chemicals, packaging, textiles, etc is preferred
• Working experience with External Manufacturing and Contract Laboratories is preferred
• Computer Skills (Word®, Excel®, PowerPoint®, Minitab®, Visio®, Microsoft Project®) is preferred
• This role can be in based in any U.S. Ethicon based location including Cornelia, GA
• Experience and/or knowledge with machining manufacturing processes and injection molding is preferred
• Knowledge and understanding of FDA and international regulatory standards for medical devices is preferred
• Basic knowledge in Statistics, Sampling Planning, Risk Assessment and Process Validation preferred
• Effective communication at all levels within Quality cross functionally with departments such as R&D, Operations, Medical Affairs, Compliance, Manufacturing