Offer description

$ 4,000.00 (monthly) Permanent contract Full Time
Company Overview
Since its inception in 1991, the company has been committed to producing premium quality non-woven single-use medical apparel. Its products are carefully designed to provide exceptional barrier protection, while still offering comfort and breathability in order to meet a wide variety of applications. Today, the company is well known as a leading manufacturer and exporter of non-woven medical disposables in Malaysia.

Responsibilities:

• To plan, prepare appropriate audit programs and execute audits on timely basis for all sections / functions.
• To conduct audits that covered system audits, process audits and product audits to determine the compliance, its implementation, effectiveness of controls and accuracy of management systems and operations in compliance with ISO 13485, FDA, MDR guidelines and company established procedures.
• To conduct audit with complete independent execution, ensuring that all findings are sufficiently documented and filed with adequate supporting objective evidence.
• To prepare and distribute audit report with audit findings for every section / function audited.
• Record and issue any Non-Conformance Report (NCR) related to non-conformance matters (i.e. documentation, implementation, work method statement, GMP, etc) and recommend corrective measures when necessary of all sections / functions audited in order to ensure that the sections / functions are in conformity with requirements as specified in the procedures / work instructions, and the relevant standard and/or regulatory requirements.
• To perform follow up audits on the corrective actions taken; as well as to ensure that the corrective actions taken are fully implemented as required and in proper closure manner.
• To compile all audit reports / findings for trend analysis. Periodically produce audit trend analysis and make recommendation to improve quality control within all sections / functions audited.
• To perform or assist in the performance of special reviews / audit at the request of the Management.
• Assists in review existing procedures and any amendments which are necessary due to changes in applicable to the standard and/or regulatory requirements.
• Assists in preparation of all Quality Document associated with the manufacture of medical devices to ensure in compliance with ISO 13485, FDA and MDR guidelines.
• Assists in the preparation, coordinating and handling the internal and external audits.
• Assists in compiling data and quality trends for management reviews.
• To observe the company policy.
• To follow the company safety rules and regulations in daily operation.
• Other assigned duties as required by superior.

Requirements:

• Bachelor\xe2\x80\x99s degree or equivalent, preferably in Scientific or Engineering discipline, or Diploma or equivalent with five years working experience, preferably in a QMS and/or cGMP environment, is required.
• Knowledge of disposable medical devices manufacturing process, audit, validation, QMS, cGMP, FDA in a regulated environment is preferred.
• Ability to work independently with minimum supervision.
• Ability to perform statistical analysis.
• Strong computer skills are preferred.
• Good written and oral communication skills.
• Good leadership skills.
• Good interpersonal skills.
• Good discipline and attitude.
• Systematic and positive problem-solving approach.
• Willing to work in Klang, Selangor

AP Carriera Talent Resources Sdn Bhd Requirements

• Minimum education level: Bachelor\xc2\xb4s Degree
• 3 years of experience