We can also be a Quality Engineer based on qualifications.
SUMMARY
The Quality Assurance Lead will lead End- to- End product quality management and QMS compliance (ISO 13485, FDA GMP). Drives continuous improvement, cross- functional problem- solving, non- conforming product disposition, and NIST- traceable calibration systems. Requires strong communication, independent work capabilities, and a customer- centric, risk- based mindset.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Be able to work through ambiguity and changes, with support to the cross functional teams of quality efforts.
Build and direct the product quality function, work scope includes customer, product and process, supplier quality, metrology, audit, incoming inspection, calibration, and quality compliance.
Embrace risk management and ensure a risk base approach is utilized to mitigate high potential failures within the facility and our processes.
Communicate product failures and drive architecture, engineering, and change management to improve product quality. Lead MRB team to manage and disposition non- conforming products.
Help develop and implement appropriate inspection techniques to support control plans and ensure product compliance through statistical techniques and appropriate sampling plans. Maintain a calibration system for all metrology, facility gauges, and production assets which are compliant to NIST traceable standards.
Good interpersonal and communication skills (Written and Verbal) to manage tough and challenging projects with little guidance to work independently.
Lead cross functional problem- solving teams to drive product and process improvement, use of QA methodologies to manage and facilitate issue resolution including root cause analysis and the development, implementation, and monitoring of effective corrective and preventive action.
Set and maintain the most up to date standard for product quality related. Lead quality reviews during the launch period, support factory and company leadership for decision making.
Serve as Management Representative to facilitate compliance requirements to meet ISO13485, FDA GMP, process validation and all associated regulatory requirements of medical device industry and customer requirements. QMS management including internal audit and management review, document, record control, ECN/DCN/QCN approval, Quality Management System review & improvement, and implementation.
Excellent problem- solver having a strong quality and customer focus mindset and possessing the personal drive for success with professional skills.
Support improvement efforts for quality data system, first pass yield, scrap, and continuous improvement opportunities in order to implement the best practice in operations.
