Medical Device Quality Manager
3 weeks ago
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
- Coordinate quality engineering activities to achieve business objectives.
- Prepare and manage equipment qualifications and analytical method transfers/validations in compliance with regulatory/requirements.
- Support site production and engineering functions in process quality improvement activities.
- Assist with internal and supplier audit processes.
- Initiate and lead discussions with contractors and vendors.
- 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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