Sr. Quality Manager/Quality Director

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GN Group
Kulai
MYR 250,000 - 300,000
Be among the first applicants.
7 days ago
Job description

Quality Assurance & Control (Manufacturing, Transport & Logistics)

Full time

  • Take the responsibility of Quality Assurance for GN Resound JB.
  • Contribute to strategic planning and decision making at the top executive level to align the company with the vision, mission, and long-term objectives of the corporate organization.
  • Develop and implement quality systems together with quality control programs to achieve high-quality products and quality systems.

Main Responsibilities:

  • Assume the responsibility for quality system management representative, and the responsible engineering manager.
  • Establish the general quality strategy of the company and determine the quality policy and objectives.
  • Establish, implement, and improve the quality management system, setting quality standards and related quality system documentation and control of implementation.
  • Oversee the operation of the QA team to ensure product quality meets the requirements of medical device regulations, company policy, and customer/procedural requirements.
  • Establish and optimize the inspection standards of incoming, process control, and finished goods, and monitor performance. Establish processes to ensure final devices conform to regulatory requirements and specifications, driving improvements through findings.
  • Drive improvements through customer complaints.
  • Approve department-related quality system documents and the closure of quality system nonconformities.
  • Approve closure of CAPA related to product quality.
  • Continuously contribute, develop, and implement ideas that improve performance.
  • Proactively join in supplier quality performance management, collaborating with engineering and procurement departments to assess suppliers.
  • Handle internal and external customer complaints, communicating with customers and quality control on quality and related issues.
  • Conduct internal quality audits, initiating and participating in management reviews.
  • Provide essential and basic skill training for the quality department and enhance the quality concept of employees in the organization.
  • Follow customer/external audits.
  • Professionalize all quality systems and personnel, moving from inspecting quality to designing and ensuring process quality.
  • Develop and implement document control programs, interface with global customers, and design and implement vendor programs for quality systems.
  • Provide customers globally with quality service to support sales and marketing.
  • Maintain and develop quality systems.
  • Ensure implementation and adherence to Health, Safety & Environmental (HSE) procedures in areas of responsibility.
  • Any other tasks assigned by the superior.

Requirements/Skills:

  • Strong ability in production procedures and quality control.
  • Leadership skills and strong business sense.
  • Familiarity with electronic production procedures.
  • Strong data analytical and problem-solving skills.
  • Fluency in both oral and written English; computer skills.
  • Knowledge of FDA QSR Part 820 (Class 1 and Class II Medical Devices).
  • Familiarity with Medical Device Single Audit Program (MDSAP).
  • Knowledge of ISO13485 (current version).
  • Understanding of the Medical Device Act 2012 (Act 737).

Other Requirements:

  • High responsibility.
  • Good team player.
  • Good personality.
  • Good summary and presentation skills.
  • Systematic and global mindset.

Qualification and Experience:

  • Above 10 years of related management experience.
  • Diploma/Bachelor and above, major in Engineering or Science.

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Your application will include the following questions:

  • Which of the following statements best describes your right to work in Malaysia?
  • Which of the following types of qualifications do you have?
  • How many years' experience do you have as a Quality Director?
  • How many years' experience do you have in a quality control (QC) role?
  • Are you willing to undergo a pre-employment background check?
  • How much notice are you required to give your current employer?

Company Overview:

Manufacturing, Transport & Logistics, 101-1,000 employees.

GN ReSound is among the world's largest manufacturers of hearing aids. Since the company was founded in 1943, GN ReSound has been known for great sound quality, design excellence, and meaningful solutions that help hearing-impaired people rediscover natural sounds.

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