**Job Title:** Senior Quality Assurance Specialist
Description:
We are seeking a highly skilled and experienced Quality Assurance Specialist to join our team. In this role, you will be responsible for ensuring the highest quality standards in our products and processes.
Key Responsibilities:
* Managing the activities of Quality Inspectors to ensure optimal efficiency and compliance with regulatory requirements
* Driving root cause analysis of non-conformances and ensuring corrections are implemented
* Maintaining cGMP practices across operational departments
* Release batches in SAP from packaging to sterilization and final release
* Liaising with personnel regarding product flow through the QC department
* Reviewing, analyzing, and reporting on customer complaints and instituting corrective actions
Requirements:
* Degree in Science/Engineering discipline (Polymer Science/Engineering or Mechanical Engineering preferred)
* Previous experience in ISO 9001/2000 or ISO 13485 environment
* Background in Medical Devices/Pharmaceutical Industry
* Knowledge of Statistical Process Control and Six Sigma methodologies
* Experience in CAPA system management and FDA requirements
* Familiarity with SAP and TrackWise
* Ability to work in process validation and clean room environments
Benefits:
* Competitive salary and benefits package
* Opportunities for career growth and development
* Collaborative and inclusive work environment
* Recognition and rewards for outstanding performance
Why Work With Us:
* We value diversity and inclusion in the workplace
* We offer equal opportunities for all employees
* We provide a safe and healthy work environment
* We support employee well-being and work-life balance