Head of Quality (EMS Industry)

Position:         Head of Quality

Location:        Malaysia

Company:      Our Client is a leader in Electronics Manufacturing Services

 

 Job Summary:

Maintenance and execution of quality assurance related activities and enhancement:

  1. Supplier Quality Engineering & IQC
  2. PCBA Quality Assurance
  3. Product Quality and Assurance Systems and Culture

 

Responsibilities:

  • Independently lead/participate in compliance audits and identify compliance gaps or risks
  • Work with customers to ensure that the site set the quality standards in compliance with quality expectation and demand by customers
  • Notify Management of potential quality or regulatory issues that may affect product quality or regulatory compliance
  • Provide quality compliance and expected standards to internal and external customers
  • Drive quality process transformation to achieve high quality standard, shifting from reactive to preventive mode, with Lean-Sigma & Kaizen approach
  • Lead on matters concerning the development, maintenance and monitoring of the Quality System
  • Initiate actions to prevent the occurrence of product non-conformity and system deficiency
  • Investigate into any product non-conformance or matters affecting the Quality System
  • Set Quality Standards to meet customer requirements
  • Support NPI, to build a robust quality assurance process
  • 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 life sciences/medical devices requirement
  • Be the overall ‘Quality Champion & Ambassador’ for the entire site in promoting 5S, Lean-Sigma and Kaizen culture

 

Requirements:

  • Degree in Electronics / Electrical / Mechanical Engineering
  • Diploma holders with at least 10 years of relevant experience will also be considered
  • At least six (6) years of hands-on product quality working experience. Independent and good technical problem solving skill working with cross-functional team
  • Has been in senior manager role for at least 3 years
  • Expertise in leading or managing ISO14001, ISO9001 & TS13485 (the minimum)
  • Expertise in leading or managing Quality Systems and GMP within a regulated environment
  • Practical understanding of CFR Title 21 (parts 820 and 11)
  • Understanding and familiarity with 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 know how and experiences in shop-floor control system – Detection & Prevention capability
  • Proven capability and experiences in leading and managing Quality escalation management
  • Statistical quality control experience and knowledge

 

Key Attributes:

  • Strong communication & presentation skills
  • Proven leadership to overcome roadblocks to drive changes
  • Ability to challenge status quo & think out of box
  • Disciplined, action-oriented and organized in thought process
  • High EQ in managing quality crisis and good people skill to influence cross-functional members (particularly production team)

 

Job-Related Skills:

  • Quality Tools (acceptance sampling plan, SPC, MSA, FMEA, PPAP, APQP or 7 QC tools, etc)
  • Statistical analysis
  • IPC, MIL, Jedec, etc standards
  • Familiar with the product quality requirement of DNA Analyzer
  • Lean-Sigma and Kaizen
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