Description

SECTION 1: JOB SUMMARY*

The Process Quality Engineer provides technical knowledge towards the identification of the causes for non-conformances and process failures, and for the implementation of the immediate, corrective and preventive actions thus compliance with all applicable regulatory requirements and company policies for the entire Business Unit manufacturing process.

SECTION 2: DUTIES & RESPONSIBILITIES*

Under and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

o Reviews and analyses quality trends with the manufacturing team. Considering the quality trends, recommends actions for process, equipment and system improvement.

o Provides guidance to manufacturing supervisors to ensure that effective in-depth investigations are performed.

o Provides guidance within cross functional, multilevel technical teams to assure causes of non-conformance are identified and that sound corrective/ preventive actions are implemented.

o Review and actively use process and documentation Key Performance Indicators to identify improvement opportunities and drive or support activities to increase performance.

o Evaluation of the implemented corrective and preventive actions against trends to assess effectiveness of the same.

o Analysis of data and based on the trends recommends actions for process, equipment and system improvement.

o Responsible and accountable as leader of project management (e.g. CAPA lead, internal Observations lead) including managing internal and external resources

o Applies the J&J Quality procedures and Six Sigma principles

o Applies the standards of the J&J related Change Management principles

o Ensures safe working conditions and practices in the department as well as providing support on the plant safety training requirements.

o Responsible for communicating business related issues or opportunities to next management level

o For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable

o Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures

o Performs other duties assigned as needed

Qualifications

SECTION 3: EXPERIENCE AND EDUCATION*

o At a minimum, Bachelor’s degree (Engineering or equivalent in a Life Science, Engineering, or Physical Science field). Master’s degree preferred.

o Experience in the QSR/ISO-regulated medical device operation preferred

SECTION 4: REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS *

o Distinct communication skills

o Distinct analytical thinking capabilities, prudent risk taking

o Six Sigma and/or Lean education and/or other sound statistical knowledge

o Thorough knowledge in QSR, GMP, ISO, knowledge in applied statistics and failure mode analysis techniques

o Proficient in the preparation to technical reports and presentations

o Good MS Office knowledge

o Sound knowledge about technical standards and legal requirements

o German, fluent speaking and the ability to describe complex technical topics understandable

o English, fluent speaking and the ability to describe complex technical topics understandable