Quality Assurance Manager

2 weeks ago


Suzhou, Jiangsu, China Phillips-Medisize Full time

Job Summary

Phillips-Medisize seeks a Quality Assurance Manager to oversee the normal operation of the Quality laboratory, ensuring compliance with GLP guidelines. The ideal candidate will have experience in resource planning, training, coaching, qualification, and performance review.

Key Responsibilities

  1. Manage QC leaders, quality technicians, and inspectors, including resource planning, training, and performance reviews.
  2. Ensure daily management of the Quality lab, including manpower, equipment, samples, data, and environment, to comply with GLP guidelines.
  3. Qualify test equipment and test methods, and perform calibration and preventive maintenance of measuring or monitoring equipment.
  4. Execute process validation or revalidation, including MSA and process capability studies.
  5. Monitor process stability and continuously improve control processes, analyzing inspection data, environmental monitoring data, deviations, CAPAs, and non-conforming material/products.
  6. Organize MRB meetings and support the CI team in continuous improvement efforts.
  7. Manage all non-conformities occurring in the Quality lab and inspection teams.
  8. Perform other duties as assigned by the supervisor.

Requirements

Required: College degree in a relevant field.

Preferred: Bachelor's or higher degree in Mechanical Manufacture and Production Engineering Technology, with knowledge of GMP and ISO13485.

Required skills include good communication skills, fluency in English, strong problem-solving skills, knowledge of FMEA/SPC/QC 7 tools, and good analytical skills.

Preferred skills include experience with CMM/OGP programming.



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