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Customer Quality Engineer

4 months ago

Peachtree City, United States Gerresheimer Full time
Company Description

Gerresheimer is the global partner for pharmaceutics, biotech, healthcare, and cosmetics with a very broad product range for pharmaceutical and cosmetic packaging solutions and drug delivery systems. The company is an innovative solution provider from concept to delivery of the end product. Gerresheimer achieves its ambitious goals through a high level of innovative strength, industrial competence and concentration on quality and customer focus. In developing innovative and sustainable solutions, Gerresheimer relies on a comprehensive international network with numerous innovation and production centers in Europe, America and Asia. Gerresheimer produces close to its customers worldwide with around 11,000 employees and generated annual revenues in 2022 of EUR 1.8bn. With its products and solutions, Gerresheimer plays an essential role in people's health and well-being.

Gerresheimer Peachtree City L.P. was established in 1993 in Peachtree City, GA, as part of the Plastics & Devices Division manufacturing and assembling a variety of precision molded plastic parts for various applications in the medical industry. The subsidiary operates in an 87,500 sq. ft. production facility with 200 employees.

Job Description

Responsible Quality representative for a defined customer, product portfolio respectively over the whole product lifecycle.

- Independent processing of customer complaints

- Leading argumentative discussions with customers with regards to quality related matters

- Quality representative regarding defined customer during audits

- Responsible to ensure compliance to customer specific relevant quality norms and requirements (e.g. CRS, SCS, QAA) during qualification and routine production

- Self-reliant initiation and implementation of quality improvements and site initiatives

- Responsible processing of change requests

- Responsible for validity of assigned PMF/DMR documentation including, risk management, creation/revision of documents, ensuring the implementation of requirements

- Oversight over internal issues including usage disposition decision of concerned batches

- Operational contact towards Customer for Raw Material / Components and Finish good product Quality

- Support production regarding quality related tasks

Qualifications

Knowledge acquired within the framework of at least 3 years of technical (technical) university studies (e.g. mechanical engineering, industrial engineering or similar) and expanded through at least three years of experience in a comparable position. This function requires special knowledge in the areas of quality management and project management.
  • In-depth knowledge of manufacturing processes (e.g. products and processes)
  • In-depth knowledge of relevant QM guidelines
  • In-depth knowledge of relevant EDP/IT applications (e.g. Office programs, MES, QM system)
  • In-depth knowledge of customer relationship management in the technical environment
  • In-depth knowledge of statistical QM methods
  • Very good knowledge of English (spoken and written)
  • Very good understanding of the preparation of technical reports (executive summary)
  • Very good moderation and presentation skills
  • Very good analytical and conceptual skills
  • Very good project and process management skills
  • Good knowledge of problem solving methods (KT, Six Sigma, Ishikawa etc.)
Additional Information
  • Mon - Fri / 40hrs
  • 8:00am - 5:00pm
  • Company health benefits, 401k, incentive bonuses