Responsible for maintenance and execution of quality assurance related activities and enhancement
1) Supplier Quality Engineering & IQC and 2) PCBA Quality Assurance 3) Product Quality and Assurance Systems and Culture
Develops, establishes and maintains quality assurance programs, policies, processes, procedures and controls ensuring that performance and quality of products conform to established standards, agency guidelines and customer requirements.
Responsible for establishing continuous improvement programs for all the company, defining and implementing the quality policy and guidelines, and homogenizing 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
Serves as a Management Representative for the associated site.
Be the overall ‘Quality Champion & Ambassador’ for the entire site in promoting 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 life sciences/medical devices requirement.
Maintain quality engineering programs, standards and improvements within the organization.
Support Customer Focus Team with customer interfaces as necessary on quality related issues.
Responsible for authorizing the released of final products to customer.
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
Provide liaison to various regulatory bodies
Develops, implements and coordinates product assurance program to prevent or eliminate defects in new or existing products.
Contribute to the workplace safety and health improvement for the employees, as well as environmental protection by adhering to the company’s Environmental, Health and Safety policies and procedures, and helping to achieve EHS objectives and targets through of EHS program.
· 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 knowhow 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.
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)
· 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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