What are the responsibilities and job description for the Quality Engineer position at Gerresheimer?
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 132 K sq. ft. production facility with 200 employees.
Job Description
- Independently plan and oversee Risk Management Activities for medical devices, including A-Risk Analysis, D-DMEA, and P-FMEA, in compliance with ISO 14971.
- Collaborate with risk management staff to conduct Risk/FMEA assessments.
- Serve as the primary contact for customers on quality-related matters, ensuring efficient coordination and communication.
- Define and implement Validation Strategies based on regulatory and customer requirements, following a risk-based approach, and document them in VMP and CRS/PRS.
- Oversee validation activities, ensuring alignment with the Validation Master Plan, product specifications (CRS), and qualification/validation plans.
- Establish and execute criteria for visual inspections of parts and assemblies during qualification and validation activities.
- Plan and manage Product Design Verification Activities independently.
- Define quality requirements for purchased parts and coordinate with suppliers to ensure compliance with these standards.
Qualifications
Qualifications:
- Technical education or equivalent qualification, such as a degree in mechanical engineering or training as a mechanical/injection molding technician, with at least 5 years of professional experience in the medical or pharmaceutical industry.
- Extensive experience in the field of Quality Engineering or Quality Management.
- Proficient in office software including SAP, MS Excel, MS Word, and MS PowerPoint at an advanced level.
- In-depth knowledge of relevant standards, such as ISO 13485, ISO 15378, 21 CFR 820, and ISO 14971.
- Strong understanding of statistical and quality management methods at a professional level.
- Excellent analytical skills, with practical experience in systematic problem-solving techniques such as KT, Six Sigma, and Fault-Tree Analysis.
Additional Information
Your contact person: Gabrielle Holland ([email protected])
All your information will be kept confidential according to EEO guidelines.
