Key Responsibilities
As a Quality Assurance Specialist, you will be responsible for developing and maintaining quality assurance programs, policies, procedures, and controls for pre-production supplier qualification and capability development.
About the Role
This role requires collaboration with manufacturing, supply chain, and procurement leaders to strengthen and improve EMI supplier management and governance.
Main Responsibilities
* Identify process improvements within the QMS to enhance compliance and quality of products delivered from suppliers.
* Provide expert-level understanding of qualification and validation requirements and deploy them in a large-scale business.
* Support design, development, and manufacturing operations in resolving supplier quality issues and implementing corrections.
* Lead supplier quality efforts during FDA and notified body site inspections.
* Maintain effective supplier-related quality metrics and define activities to improve performance.
* Review and evaluate supplier quality data to identify process improvement opportunities within the supply chain.
* Establish a Critical-to-Quality (CTQ) program focusing on critical supplier processes and characteristics.
* Evaluate supplier activities against domestic and international medical device standards, directives, and regulatory requirements.
* Promote continuous improvement techniques such as Lean, Six-Sigma, Poka-Yoke, and FMEA.
* Execute the supplier qualification/approval process through onsite and virtual audit activities.
About You
You are a proven leader with over ten years of experience in Electromechanical Instrumentation, Quality Assurance, FDA regulations, lean manufacturing, and ISO standards. Your skills include:
* Deep knowledge of medical device regulations such as MDD/MDR, IVDD/IVDR, MDSAP, CMDR, and ISO 13485.
* Excellent project management and organizational skills.
* Able to manage multiple projects simultaneously and influence cross-functional teams.
* Strong communication skills for presenting key initiatives.