Johnson & Johnson Karrieren
Associate Quality Engineer
Requisition ID: 1905736334W
- Be responsible for the complaints at the site
- Conduct investigation, bounding, documentation of non-conformances,CAPAs and customer complaints. Escalation of quality issues as appropriate.
- Creation and optimization of test plans
- Release of qualifications and validations
- Support in the TMV document preparation
- Working in conjunction with other senior Quality Engineers/Senior Quality Engineers to review the level of control in manufacturing processes including the adequacy of current process limits.
- Working in conjunction with other senior Quality Engineers/Senior Quality Engineers to assess the current risk mitigation techniques implemented and whether these are consistent with the product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc
- Champions compliance to applicable Global Regulations and standards (e.g. QSRs, ISO, EN and Medical Device Directive (MDD) requirements) including providing support during internal and external audits.
- A minimum of a Bachelors Degree, preferably in Engineering or related technical field. Generally requires 0-2 years related experience.
- Process Validation expertise is required.
- Test Method Validation (TMV) expertise is preferred.
- Good technical understanding of manufacturing equipment and processes is required
- Knowledge of inspection planning process is required (Understanding of validation, technical drawing, PRA/PFMEA)
- Technical training and experience using Statistics, Lean and Six Sigma Methodologies is preferred including Measurement System Analysis, SPC, DOEs, Reliability, etc.
- Knowledge of statistical software packages is preferred with the ability to preview, graph and analyse data and be able to present data that facilitates/drives decision making.
- A thorough understanding of GMP/ISO regulations and validation regulations is preferred
- Pronounced technical understanding
- Analytical thinking
- Ability to create technical documentation
- very good English and good German
Synthes Produktions GmbH (7117)