Quality Operations Manager – Analytical SyringesID:60345

10,000 MYR ~ 12,000 MYRニボン・テバル Nibong Tebal約9時間 前

概要

  • 給与

    10,000 MYR ~ 12,000 MYR

  • 業界

    Manufacturing(Pharmaceutical/Medical Equipment)

  • 仕事内容

    The Quality Manager is responsible for ensuring that the Analytical Syringe Business Unit in Malaysia consistently meets customer expectations for product quality, responsiveness, and reliability. This role is critical in maintaining a strong quality culture across the manufacturing lines and supporting quality-related functions throughout the business.

    - Provide management and oversight of the QMS functions related to and supporting Analytical Syringe manufacturing in MYS, such as customer complaints (OQR’s), CAPA, IQC, OBI, etc. to support the business meeting customer needs efficiently and effectively.
    - The deployment and day-to-day management of Quality resources to work directly with the business functions on identifying and resolving inefficient processes.
    - Providing 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.
    - Managing the IQC and OBI function, including calibration and supplier chain quality performance.
    - Effectively managing the Business Unit Quality resources.
    - The regular review of 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 relationships with customers.
    - Maintain strong communication with Product Management and other key stakeholders.
    - Support training in core Quality skills within the Analytical Syringe BU MYS.
    - Performance reporting – Monthly Quality reports, Quarterly DEFOA report, Internal performance reports.

求めている人材

  • 応募条件

    - Degree in quality management, a science or 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 9001 or 13485.
    - Experience in a senior quality or operations role within a technical engineering business.

    Skills/Knowledge/Abilities:
    - Strong knowledge of Quality Systems– ISO 9001 and or ISO 13485
    - An understanding of Risk Management principles and application in an ISO 9001 environment
    - Internal auditor accreditation.
    - A business acumen with the ability to translate customer quality needs to the manufacturing line in
    an efficient and effective way.
    - Ability to achieve outcomes through the actions of others.
    - Ability to generate reports that meet the protocols of the QMS and the report’s objectives
    - Strong communication and listening skills
    - Ability to foster knowledge sharing
    - Strong knowledge of Microsoft Suite of packages

  • 英語

    -

  • その他言語

    Malay, English

その他