Quality Operations Manager – Analytical SyringesID:60854

10,000 MYR ~ 12,000 MYRニボン・テバル Nibong Tebal8日 前

概要

  • 給与

    10,000 MYR ~ 12,000 MYR

  • 業界

    -

  • 仕事内容

    - Provide management and oversight of the QMS functions related to and supporting Analytical Syringe manufacturing in MYS, such as customer complaints (OQRs), CAPA, IQC, OBI, etc., to support the business meeting customer needs efficiently and effectively.
    - Deploy and manage day-to-day Quality resources to work directly with business functions on identifying and resolving inefficient processes.
    - Provide QMS advice to relevant business functions, including QA, with respect to product and process.
    - Lead the management of customer complaints and CAPA processes to ensure timely resolution and communication.
    - Maintain strong communication with customers to support quality-related inquiries and feedback.
    - Manage the IQC and OBI functions, including calibration and supplier chain quality performance.
    - Effectively manage the Business Unit Quality resources.
    - Regularly review product, process, and systems as part of continual improvement.
    - Perform regular internal audits (formal and informal) of the manufacturing line.
    - Support the transfer of developed Analytical Syringe products (excluding Medical Devices) from R&D to production, or site transfers.
    - Support the MYS site in preparing for second-party and third-party audits and risk-based internal audits.
    - Maintain strong communication with Product Management and other key stakeholders.
    - Support training in core Quality skills within the Analytical Syringe BU MYS.
    - Provide performance reporting – Monthly Quality reports, Quarterly DEFOA report, and internal performance reports.

求めている人材

  • 応募条件

    Requirements:
    - Degree in quality management, a science, or an engineering field (preferred) or equivalent.
    - Minimum 5 years’ experience in a senior Quality role within a scientific or engineering organization or strong process experience within an organization with an integrated QMS certified to either ISO 9001 or ISO 13485.
    - Experience in a senior quality or operations role within a technical engineering business.
    - Strong knowledge of Quality Systems – ISO 9001 and/or ISO 13485.
    - Internal auditor accreditation.

    Advantages:
    - Understanding of Risk Management principles and application in an ISO 9001 environment.
    - Business acumen with the ability to translate customer quality needs to the manufacturing line.
    - Strong knowledge of Microsoft Office suite.

  • 英語

    -

  • その他言語

    Malay, English

その他