Director of Quality (Medical Device)

Position           : Director of Quality (Medical Device)

Location          : Singapore and Malaysia

Industry           : Electronics Manufacturing Services (Medical Device)

 

JOB SUMMARY

Responsible for a function to review and enhance quality assurance system and resources to ensure our products, services and solutions are in compliance with all applicable regulatory and customers’ requirements for quality, design & manufacturing process validation and reliability standards.

 

JOB RESPONSIBILITIES

Lead the Division quality function with overall responsibility to implement, manage and review the entire quality system (policies, processes, training and audits) to all sites (or other sites assigned from time to time) to ensure consistent quality mindset & practices are applied

  • Build strong working relationship with site management teams as well as externally with customers and regulatory agencies
  • Develop, establish and maintain quality assurance programs, policies, processes, procedures, controls and training to ensure that performance and quality of products conform to established standards, agency guidelines and customer requirements
  • Establish continuous improvement programs, define and implement the quality policy and    guidelines, and homogenize the quality systems in order to detect, solve and prevent problems in the manufacturing processes
  • Ensure compliance with Company’s Quality System and applicable regulatory requirements
  • Be the overall ‘Quality Champion & Ambassador’ to promote 5S, Lean-Sigma and Kaizen culture.
  • Lead a team of Engineers, Staff Engineers and Quality function leaders

 

Build QA capability, provide technical leadership, and introduce best practices

  • Generate quality plans, control plans, procedures, work instruction for overall quality and coordinate on effective implement of such plans, procedures or instructions in compliance of regulatory requirements such as FDA, etc
  • Maintain high-quality-assurance design services, engineering and manufacturing programs, standards and improvements within the organization
  • Support Commercial team with customer interfaces where necessary on quality related issues, including quality escalation issues
  • Interface with manufacturing, engineering, and customer representatives to develop quality systems and ensure compliance, determine responsibilities and solutions when required
  • Responsible for managing customer audits and regulatory/compliance agency audits

EDUCATION and EXPERIENCE

  • Degree in Electronics / Electrical / Mechanical Engineering
  • At least 8-10 years of hands-on product quality working experience. Independent and good technical problem solving skill working with cross-functional team
  • Expertise in leading or managing ISO14001, ISO9001 & TS13485. (the minimum)
  • Expertise in leading or managing Quality Systems and GMP within a regulated environment
  • Having audit experience and good understanding of FDA regulatory requirements, guidelines and recommendations
  • Proven track records of driving continuous improvement or Kaizen in reducing DPPM (quality defects) and in driving major quality process changes to institute “standard work” and reduce “variations”
  • Proven knowhow and experiences in shop-floor control system – Detection & Prevention capability
  • Proven capability and experiences in leading and managing Quality escalation management

 

JOB-RELATED SKILLS & PRE-REQUISITES

Business and Operational Management

  • Demonstrate perceptive and organising ability to identify weak links, balance conflicting needs, string up different functions, execute swift actions with a sense of urgency to address and meet the needs of business and build strong customer relationship on win-win partnership
  • Demonstrate strong business-acumen and customer satisfaction centric mindset and ability in DECISION-MAKING that is substantiated by strong knowledge and critical thinking

People Leadership

  • Strong leadership in team development and teamwork enabled by strong interpersonal, influencing and conflict resolution skills
  • Proven track records in developing future leaders
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