Senior Manager, Quality Assurance Engineering

**Job Description Summary**:
**Who We Are**

**Job Summary**:
Manages all Quality Assurance & engineering activities associated with the product development, product support and quality processes in Greater Asia manufacturing facilities. Ensures that all quality-related systems for R&D and product are established and documented to provide a safe and effective product that meets customer needs. Establishes and administers Quality Assurance/ Quality Systems, policies and procedures which will enable R&D to respond rapidly to customer needs. Provides leadership, quality oversight and direction, scheduling, decision-making, problem-solving and team-building capabilities.

Supports Senior Director of Manufacturing & Design Quality, Greater Asia to provides managerial and technical support to the Greater Asia Manufacturing plants and Design Centers (Unit Quality).

**Role Responsibilities**:

- Manages Quality Engineering staff and guides the Singapore Quality groups to support product development.
- Support Senior Director of Manufacturing & Design Quality, Greater Asia in providing managerial and technical support to Greater Asia Manufacturing plants and Design Centers (Unit Quality).
- Oversees the development, maintenance, and continuous improvement of quality systems in accordance with 21 CFR 820 and ISO 13485.
- Management Representative (MR) for Design Center and representing management during ISO audit.
- Ensures compliance with all local, state, and federal regulations, as well as BD quality policies, procedures, and practices, through effective communication, training, and education in quality assurance principles.
- Oversees design control compliance within the business's phase gate product development process. Direct the evolution and enhancement of the product development process.
- Coordinates and leads cross-functional planning, coordination, and reviews. Initiates and directs QA/ QS programs to ensure the successful introduction of new products and processes in accordance with the strategic plan.
- Responsible for leading risk management activities for products under design authority.
- Manage R&D design and product design transfer activities for complex NPI projects in collaboration with cross-functional stakeholders such as R&D, Supply Quality, Supply Chain/Procurement, Technical Operations, Manufacturing Plant, and Plant Quality throughout the Greater Asia Region.
- Supports quality initiatives for plant issues. Work closely with Manufacturing to resolve customer complaint issues by identifying root causes and developing corrective actions for design related issue
- Able to influence Quality Engineering and R&D activities and strategies at Business Unit/Region level. Participate in R&D portfolio analysis. Ensure quality and accuracy of integrated project plans encompassing all cross-functional activities.
- Defines actionable metrics for measuring Quality Engineering performance against business objectives, monitoring on a regular and frequent basis to identify and mitigate gaps as they arise.
- Ensure proper assembly and maintenance of the Design History File (DHF).
- Work as a part of the Leadership team to assist the Sr Director by sponsoring innovative ideas to improve Quality operation, by recommending, supporting, and implementing continuous improvement activities in processes and procedures to optimize results to improve quality of delivery, meeting quality standards requirements deliverable in accordance with Company and Customer requirements.
- Support activities relating to Field Corrective Actions, when needed. Collaborating and gathering data from plants and unit quality organization to identify and interpret performance trends/ Metrics.
- Analyzes, summarizes, and communicates pertinent information to management. Ensure timely, accurate, and complete data reporting. Implement benchmark and best-practice activities to maintain exceptionally high levels of product quality and compliance across Greater Asia Region manufacturing plants.
- Analyze, create, and recommend quality engineering approaches to meet manufacturing and design quality and production requirements.
- Develop and implementation the quarterly/annual Greater Asia Plant Quality Performance Excellent program
- Any other assignment assigns by the direct manager

**Knowledge. Skills and Experience**
- Bachelor’s degree in engineering
- At least 8-10 years of managerial experience in the regulated medical device industry, with a focus on manufacturing quality and design quality
- Strong knowledge of applicable medical device regulations such as ISO 13485, ISO 14971, 21 CFR Part 820, EU MDR, EU IVDR, MDSAP and NMPA is required
- Experience in development and manufacture of Catheter, Needle, Syringe and disposable medical device is a must
- Six Sigma black belt and certified ASQ Quality Manager or equivalent
- Experience in preparing, hosting and lead FDA and other Governments’ Regulatory inspection
- Ability to work in a