Senior Quality Engineer Complaints

Johnson & Johnson

Beerse, Belgium
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Product quality complaints investigation
Failure investigations
Medical device report submission
** Johnson & Johnson is seeking a Senior Quality Engineer Complaints to lead investigations into product quality complaints for commercial and clinical products, ensuring compliance with quality standards. The ideal candidate will have extensive experience in quality assurance within the pharmaceutical or medical device sectors and will be responsible for improving complaint management processes and collaborating across various departments. **

Job Summary

  • The Quality Engineer 4 will be responsible to lead, conduct and support the investigation of Janssen Product Quality Complaints for commercial and clinical products in close cooperation with the manufacturing sites and to ensure a complete holistic investigation for PQCs is documented in the PQC database.
  • He/she acts as a single point of contact (SPOC) of PQV for the manufacturing sits and partners with the sites to raise awareness of aging/coming due/prioritization.
  • The Quality Engineer 4 leads Product Quality Vigilance projects and new business projects to ensure compliant and effective data / knowledge transfer.

Matching Summary

Match Score: 75

** Johnson & Johnson is seeking a Senior Quality Engineer Complaints to lead investigations into product quality complaints for commercial and clinical products, ensuring compliance with quality standards. The ideal candidate will have extensive experience in quality assurance within the pharmaceutical or medical device sectors and will be responsible for improving complaint management processes and collaborating across various departments. **

Skills & Requirements

Must-have

  • Product Quality Complaints investigation
  • Failure Investigations
  • Medical Device Report submission
  • QSR requirements interpretation
  • Regulatory requirements knowledge

Nice-to-have

  • Coaching and development
  • Cross-departmental collaboration
  • Continuous improvement mindset
  • Global mindset and change initiatives

Key Requirements

  • 5+ years of Quality Assurance/Control experience
  • Experience in pharmaceutical/Medical Device industry
  • 2-5 years Complaint Management/Post Market Vigilance experience
  • Knowledge of medical safety environment and regulation
  • Experience with 21 CFR parts 4, 820, 803, 806, 210, 211, 314
  • Experience with ISO 13485:2016, ISO 14971:2007/2012
  • Experience with ICH Q10, GDP, GMP, GVP, MEDEV 2.12, CMDR
  • BA/BS in technical, scientific, or engineering disciplines

Work Rights

Not specified

Tailored Resume

Cover Letter