Quality & Compliance Engineer (m/f) - initially limited to 24 months

Job description

Job Description

Requisition ID: 1805686789W

Johnson & Johnson, through its operating companies, is the world's most comprehensive and broadly-based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices and diagnostics markets. We strive to provide scientifically sound, high quality products and services to help heal, cure disease and improve the quality of life.

You are focusing on the introduction of New Products as well as managing changes throughout the Life Cycle for launched products. You ensure compliance with company policies and procedures and recommendation involving the implementation of regulatory requirements. You utilize the Quality technical tools, process and system to support appropriate execution of the quality system. In addition, you lead risk management and activities for product development and changes and guide for process changes and process deviation.

Tasks
·  Utilize Quality Engineering tools for the effective and efficient development, transfer, and maintenance of products/processes throughout the product lifecycle
·  Utilize quality engineering principles to develop and optimize products/processes that are aligned with the overall Quality and Business vision
·  Ensure effective risk management to prevent unanticipated failure modes and ensure capability
·  Develop, implement and maintain the appropriate Process Control Plan in alignment with Quality Plan
·  Ensure the development and validation of appropriate test methods for product and process performance, process controls and process risk management
·  Ensure effective quality strategies for validation
·  Ensure effective and efficient use of Quality Engineering techniques such as risk analysis, test method development, statistical data analysis, statistical process control, and development of sample plans
·  Ensure the development of a comprehensive risk management plan for the product and process
·  Ensure effective change control
·  Ensure active and thorough investigation of quality issues and effective corrective and/or preventive action

Desired profile

Qualifications

·  A minimum of a bachelor's degree is required
·  Experience in medical device or pharmaceutical manufacture
·  Professional / Technical Experience in Packaging / Textile production / Metal production desirable
·  Experienced in Risk Management (ISO 14971)
·  Familiar with ISO13485:2016
·  Internal and external audit experience
·  Experienced in Six Sigma and/or Lean methodologies (desirable)
·  Experienced in problem solving together with a multidisciplinary team
·  Basic knowledge in Q-Systems, Regulatory (Design Control, Technical Files …)
·  Good communicator who provides verbal and written communications about process improvement projects
·  Fluent in both German and English

The well-being and development of our employees are central aspects of our company creed. Individuals who would like to fully realize their potential as part of our international, innovation-driven corporate family and who aspire to have challenging work, will find that our company provides just the right conditions. We consider intensive initial training, further education that is tailored to our employees' work and excellent opportunities for development - both nationally and internationally - to be just as essential as a good work-life balance, attractive compensation and above-average employee benefits. One aspect that distinguishes our company is the large number of measures we have to support our trainees and promote career development in ways that are also compatible with family life.

Primary Location
Germany-Schleswig Holstein-Norderstedt-
Organization
Johnson&Johnson Med GmbH (7930)
Job Function
Compliance
Requisition ID
1805686789W