Offene Stellen bei Gerresheimer

Quality Engineer

650 Highway 74 South, United States | Peachtree City | Full-time

Job Description

  • Self-reliant planning and surveillance of Risk Management Activities for Medical Devices (ISO 14971, A-Risk Analysis; D-DMEA; P-FMEA)
  •  Participation in Risk / FMEA assessments in alignment with risk management staff members
  • Self-reliant coordination of quality-related matters with our customers 
  • Self-reliant definition of Validation Strategy in accordance with regulatory and customer requirements following risk-based approach (documentation in VMP and CRS/PRS)
  • Self-reliant surveillance of validation activities in accordance with validation master plan, Product Specifications (e.g. CRS) and qualification / validation plans
  • Self-reliant definition of criteria for and execution of visual inspections of parts and assemblies in the field of qualification and validation activities.
  • Self-reliant planning and managing of (Product-) Design Verification Activities 
  • Self-reliant definition of quality requirements for purchased parts and coordination with suppliers

Qualifications

  • Knowledge as obtained by technical study or equivalent technical education (e.g. mechanical technician, injection molding technician) with professional experience in the medical/pharmaceutical industry for at least 5 years Solid professional experience in the field of Quality Engineering or Quality Management
  • Solid office software experience (SAP, MS Excel, MS Word, MS Powerpoint) (Advanced Level)
  • Professional knowledge of applicable standards (e.g. ISO 13485, ISO 15378, 21 CFR 820, ISO 14971)
  • Solid knowledge of statistical / QM methods (Professional Level)
  • Performance and design motivation
  • Action orientation, conscientiousness and flexibility
  • Sensitivity and sociability
  • Sociability and team orientation
  • Emotional stability, resilience and self-confidence
  • Fluent written and spoken English (A2 / B1)
  • Good analytical competence; experience in systematic problem-solving Techniques (e.g. KT, Six Sigma, Fault-Tree Analysis)
  • Good knowledge of moderation and presentation techniques
  • Solid structured way of working

Additional Information

All your information will be kept confidential according to EEO guidelines.

Benefits

Food & drinks

We offer you a canteen and free beverages.

Learning & development

According to the job and position, we make sure our employees get regular trainings and coaching to unleash their possibilities.

Healthcare & pension

Your health and well-being is important to us. We offer a life and group insurance.

Working environment

Creating a great place to work is essential for us, so we live up to our values teamwork, responsibility, integrity, bold innovation and excellence (TRIBE).

Company Description

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 €1.4 billion. With its products and solutions, Gerresheimer plays an essential role in people's health and well-being.

Equal Rights

All applicants are considered without any regard to race, color, creed, religion, age, national origin, ancestry, ethnicity, gender, gender identity, gender expression, sexual orientation, marital status, veteran status, disability, genetic information, citizenship status or membership, or any other legally protected status.

Interested? Apply today!

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