Medical Device Quality Manager

3 weeks ago


Monrovia, California, United States STAAR Surgical Full time
Job Description

The Sr. QC Quality Engineer will be responsible for providing guidance and leadership on development/review of validation policies, master plans and schedules, protocols and quality engineering issues. The candidate must have strong knowledge of regulatory/compliance/validation issues, be self-motivated, intelligent and reliable.


Responsibilities
  1. Coordinate quality engineering activities to achieve business objectives.
  2. Prepare and manage equipment qualifications and analytical method transfers/validations in compliance with regulatory/requirements.
  3. Support site production and engineering functions in process quality improvement activities.
  4. Assist with internal and supplier audit processes.
  5. Initiate and lead discussions with contractors and vendors.
  6. Compile quality metrics, analyze trends and report to Quality Management.

Skills and Experience

Necessary Skills and Experience:

  • Five years' experience in validation and/or quality engineering in the medical device or pharmaceutical industries.
  • Knowledge of FDA Quality System Regulation and ISO 13485.
  • Experience in vision care or intraocular lens industry preferred.
  • General knowledge of manufacturing processes such as injection molding, assembly, packaging, and sterilization.


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