Sr. Quality Manager/Quality Director

GN Group; Kulai; On-site; MYR 60,000 - 100,000; Full time

Job summary

An established industry player in the medical device sector is seeking a Quality Director to lead quality assurance initiatives. This role involves overseeing the quality management system, ensuring compliance with regulatory standards, and driving continuous improvement in product quality. The ideal candidate will possess strong leadership and analytical skills, with over a decade of experience in quality control management. Join a forward-thinking company dedicated to enhancing the quality of life for individuals through innovative hearing solutions. If you are passionate about quality and compliance, this opportunity is perfect for you.

Qualifications

• Over 10 years of management experience in quality control.
• Strong knowledge of FDA regulations and ISO standards.

Responsibilities

• Manage the quality system and ensure compliance with regulatory requirements.
• Develop and implement quality management systems and standards.

Skills

Production Procedure and Quality Control

Leadership Skills

Data Analytical Skills

Problem-Solving Skills

FDA QSR Part 820

ISO13485

Medical Device Act 2012

Fluency in English

Education

Diploma in Engineering or Science

Bachelor's Degree in Engineering or Science

Job description

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

Main Responsibility:

• Assume the responsibility for quality system management representative, and the responsible engineering manager
• Establish general quality strategy of the company and determine the quality policy and objectives.
• To establish, implement and improve quality management system. Setting quality standards and related quality system documentation and control of implementation
• Oversee the operation of the QA team to ensure the product quality meet requirements of medical device regulatory, company policy and customers/procedure’s requirements.
• Establish and optimize the inspection standard of incoming, process control and finished goods, and monitor the performance. Establish process to make sure final device conform to regulatory requirements and specification, drives the improvements through the findings
• Drive the improvement through customer complaint
• Approve department related quality system documents and the closure of quality system nonconformities.
• Approve closure of CAPA which related to product quality
• To continuously contribute, develop and implement ideas that improve performance
• Proactive join in supplier quality performance management, collaborate with engineering, procurement department to assess the suppliers
• Internal and external customer complaint handling, Communicating with customers and quality control on quality and related issues
• Organizations internal quality audit, Initiate & Participate in the management review
• Essential and basic skill training for quality department and enhance the quality concept of employees in all organization.
• Follow customer /external audit
• Professionalize all quality systems and people, move from inspecting quality in to design and process quality.
• Develop and implement document control programs, interface with global customers, design and implement vendor programs for quality systems.
• Provide customers global wide with the quality service to support sales and marketing.
• Quality Systems maintenance and development
• Ensure implementation and adherence to Health, Safety & Environmental (HSE) procedures by applying to areas of responsibility
• Any other tasks assigned by the superior

Requirements/Skills:

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

Other Requirement :

• High responsibility.
• Good team player.
• Good personality.
• Good summary and presentation skill.
• Systematic and Global Mindset

Qualification and Experience :

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

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Your application will include the following questions:

What's your expected monthly basic salary? Which of the following statements best describes your right to work in Malaysia? How would you rate your English language skills? 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?

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.

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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