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Key ResponsibilitiesMonitor daily attendance and schedule work and/or mobilise the QA prepacking team to achieve the required productivity, headcount and cost based on defined cycle time.
Plan, track and verify the completion of lots for QA inspection to ensure the completion of the required task is within the expected time.
Provide guidance and coaching to QA staff in order to achieve the required competency and capability to deliver accurate results, outcome expected within the specified cycle time.
Monitor the prepacking inspection line quality performance, review and analyse quality performance trend and results to feedback operations team to analyse quality issue detected and monitor the action taken effectiveness with prompt updates.
Identify and determine associated risk and effect on type of defect found, to trigger alert and work with production team to take action as prevention to resolve and achieve consistent quality performance, to prevent lot failure.
Obtain updated changes to prepacking procedures / document/ forms in compliance with the relevant requirements.
Compile and report daily, weekly and monthly quality performance trend report for management review with observation and comments.
Report any irregularities of devices used in the inspection lines and ensure timely repairs are made to restore the devices used.
Issue Corrective Action Request (CAR) for prepacking inspection rejection to determine the root cause of the issue.
Work with production team on the CAR investigation.
Track the completion of the CAR reply and monitor effectiveness of the action taken to overcome the issue.
Safety and StandardsCultivate and enforce safe working practices, ensuring the workforce adheres to safety protocols (e.g.
usage of PPE) and compliance with safety standards, while driving initiatives toward zero lost-time injuries.
Review and ensure master defect samples and colour limit samples are established as per procedure.
Communicate changes to the standards, requirements to the quality inspectors to implement the most recent changes.
Develop Human CapitalMentor inexperienced subordinates to develop skills and provide technical leadership (formal or informal) through on the job experience as well as comprehensive understanding of the QA operational requirements.
Monitor team performance against target Key Performance Indicators (KPIs) and collaborate with QA Manager to strengthen the subordinates' competencies.
Monitor workforce compliance in accordance to prevailing policies and guidelines, such as work hours, overtime, working conditions, fair treatment, wellbeing, etc.
OthersAny other task and/or assigned duties as required by the management.
Job RequirementsMinimum Bachelor's Degree in Science / Chemical Engineering / Mechanical Engineering / Chemistry or equivalent.
Minimum 3-5 years' working experiencein related field.
Knowledge and experience in medical device regulations, validation, audit, product inspection and testing, ISO 9001 and ISO 13485 quality management systems, cGMP and FDA in a regulated environment.
Ability to work independently with minimum supervision.
Ability to perform statistical analysis.
Ability to lead and supervise a team of subordinates.
Strong computer skills are preferred.
Able to work on weekends (Off days on weekdays)
Your application will include the following questions:
What's your expected monthly basic salary?
Which of the following types of qualifications do you have?
How many years' experience do you have as a Quality Assurance Engineer?
Have you worked in a role which requires a sound understanding of ISO 9001?
How many years' experience do you have in a quality control (QC) role?
Are you available to work outside your usual hours when required?
(e.g., weekends, evenings, public holidays)
Which of these industries have you worked in?
How much notice are you required to give your current employer?
Manufacturing, Transport & Logistics101-1,000 employees
Established in 1979, Kossan is one of the largest manufacturers of latex disposable gloves in the world with an annual production capacity of 28 billion pieces and the largest technical rubber products manufacturer in Malaysia with a total compounding capacity exceeding 10,000 mt.
More than 80% of its products are exported to over 130 countries with 350 active customers mostly located in developed nations such as United States, U.K., Scandinavian Countries, Europe, China, Korea & Japan.
KOSSAN manufactures and offers a wide range of products including highly technical input engineered rubber products used in automotive, infrastructure, marine, aviation, rail and mining industries through its Technical Rubber Product Division and latex disposable gloves through its Glove Division.
The Group operates with 20 plants (19 in Malaysia, 1 in China) and has a total workforce to approximately 6,000 comprises both local and foreign nationals.
Equipped with strong manufacturing capability, KOSSAN has been the preferred OEM manufacturer and business partner by many renowned MNCs for the past 2 to 3 decades.
The Company is recognized for its capability in bringing to its customers various innovative products with a fair price and consistent product quality, professional business dealings and robust financial track record.
KOSSAN has been profitable with zero loss making record since inception and the Company joined Bursa Malaysia as a public listed company in 1996.
The Company has been in the radar of both the foreign and domestic investment community for many reasons, notably consistency in performance, proven execution capabilities, technical know-how in the rubber products industry, consistency in dividend payments and prudent management philosophies.
KOSSAN will continue to stay focused in R&D, innovation, and business transformation using technology to scale greater heights with the ultimate goal:
To deliver "LONG TERM & SUSTAINABLE GROWTH" to all its stakeholders.#J-18808-Ljbffr