Senior Customer Quality Engineer

Posted 5 Days Ago
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Peachtree City, GA
Senior level
Healthtech • Biotech • Pharmaceutical
The Role
The Senior Customer Quality Engineer will handle customer complaints, manage internal deviations and change requests, conduct risk assessments, participate in audits, and ensure compliance with quality standards. The role requires fostering collaboration across departments, leading new projects, and maintaining product-related files while ensuring adherence to legal and internal regulations.
Summary Generated by Built In

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.

Job Description

  • Handle customer complaints independently, ensuring timely and effective resolution.
  • Initiate and collaborate on the processing of internal deviations to maintain quality standards.
  • Manage change requests autonomously, ensuring smooth implementation and communication.
  • Conduct independent risk assessments and implement appropriate mitigation measures.
  • Participate in audits to support compliance with quality standards and regulatory requirements.
  • Foster effective and trusting collaboration with internal and external interfaces, including production areas, Technical Services (TS), Customer Services (CS), plant management, and external partners such as customers.
  • Lead the implementation of new projects as needed, adhering to defined specifications and timelines.
  • Ensure compliance with all applicable standards, legal provisions (e.g., Working Hours Act, occupational safety regulations), and internal company regulations (e.g., SOPs, BVs).
  • Maintain and update product-related PMFs (Process Master Files), taking into account changes and their impact on product transfers.

Qualifications

  • Knowledge acquired within the framework of at least 3 years of technical (technical) university studies (e.g. mechanical engineering, industrial engineering, etc.) and developed by at least five years of experience in a comparable position.
  • Minimum of 5 years of experience in a comparable position, with demonstrated expertise in quality and project management.
  • Advanced knowledge of manufacturing processes, including product and process workflows.
  • Expert understanding of relevant Quality Management (QM) guidelines and standards.
  • Proficiency in relevant IT applications, including MS Office, MES, and QM systems.
  • Extensive experience in customer relationship management within a technical environment.
  • Strong proficiency in statistical quality management methods.
  • Exceptional communication skills, both written and verbal.
  • Proven ability to work effectively in a team-oriented environment.
  • Outstanding problem-solving abilities and expertise in conflict resolution.
  • Fluency in English, including the ability to produce and comprehend complex technical reports (e.g., executive summaries).
  • Excellent moderation and presentation skills, with the ability to engage diverse audiences.
  • Highly developed analytical and conceptual thinking skills.
  • Strong competencies in project and process management, with the ability to lead initiatives successfully.

Additional Information

  • Mon - Fri / 40hrs
  • 8:00 am - 5:00pm
  • Company health benefits, 401k, incentive bonuses
The Company
HQ: Düsseldorf
2,246 Employees
On-site Workplace
Year Founded: 1864

What We Do

Gerresheimer is the global partner for pharma, biotech, healthcare and cosmetics with a very broad product range for pharmaceutical and cosmetic packaging and drug delivery devices. 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, focus on quality and customers. 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 10,000 employees and generates annual sales of more than €1.5 billion. With its products and solutions, Gerresheimer plays an essential role in people's health and well-being.

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