Job Overview
This is a prime opportunity for an experienced professional to contribute to shaping product and process quality in a dynamic, collaborative environment.
As a Quality Assurance Specialist, you will be responsible for ensuring compliance with regulatory requirements, applying quality engineering tools and techniques, and driving continuous improvement.
* Provide technical support during new product introduction, ensuring adherence to FDA, QSR, and MDD standards.
* Apply quality engineering methodologies, including validation protocols (DQ, IQ, OQ, PQ), cGMP, PFMEA, and DMF generation.
* Use scrap reduction strategies and process capability analysis to deliver defect-free processes.
* Support sterilization, automation, and equipment/software validation.
* Operate in controlled manufacturing environments.
* Participate in internal and external audits of the Quality Management System.
* Support the CAPA system and drive quality initiatives across departments.
* Ensure compliance with GMP, company policies, and safety programs.
* Apply root cause problem-solving in team settings.
* Align customer specifications with operational capabilities.
* 2–4 years' experience in Quality Assurance.
* Competent in Quality Management Standards.
* Skills & Attributes:
* Strong leadership and collaboration skills.
* Excellent organization, communication, presentation, and computer skills.
* Initiative-driven, solution-focused, with strong decision-making abilities.
* Performance and results-oriented mindset.