Quality Assurance Lead

Report To: Technical Project Engineer

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

1. Build and direct the product quality function, work scope includes customer, product and process, supplier quality, metrology, audit, incoming inspection, calibration, and quality compliance.

2. 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.

3. Support improvement efforts for quality data system, first pass yield, scrap, and continuous improvement opportunities in order to implement the best practice in operations.

4. Communicate product failures and drive architecture, engineering, and change management to improve product quality. Lead MRB team to manage and disposition non-conforming products.

5. 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.

6. 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.

7. Good interpersonal and communication skills (Written and Verbal) to manage tough and challenging projects with little guidance to work independently.

8. Excellent problem-solver having a strong quality and customer focus mindset and possessing the personal drive for success with professional skills.

9. Be able to work through ambiguity and changes, with support to the cross functional teams of quality efforts.

10. Embrace risk management and ensure a risk base approach is utilized to mitigate high potential failures within the facility and our processes.

11. 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.

1. Bachelor or above degree in mechanical engineering or electrical engineering related.

2. 5+ years of experience in medical device industry product quality, quality system, or program quality.

3. Experience of supervision teams in a fast-paced working environment.

4. Excellent knowledge of quality problem solving methods and statistical techniques, six sigma black belt is a plus.

5. Detail oriented, ability to effectively handle multiple priorities, flexibility to reorganize, prioritize, and reschedule work on short notice to meet tight deadlines, have a strong quality mindset and enjoy working in a team environment.

6. Clear verbal, written, and presentation communication skill in bilingual setting (English and Vietnamese).

7. Strong working knowledge of ISO 13485 standard, lead auditor certification a plus.

8. Excellent computer skills and proficient with Microsoft office with experience in statistical and document control systems preferred.