Head of Quality – Idealseed

Head of Quality 200 views



Responsibilities:

  • Overall to manage and implements Quality Management
    System and Quality Improvement programs for Medical Devices manufacturing
    facility.
  • Oversees Quality Assurance and Compliance functions.
    Work with local leadership team members in developing long and short term
    business goals and strategies.
  • Management of CAPA, Complaint Management System, Internal and
    External Audit processes.
  • Initiate and overall Management of Documentation
    Control System.
  • Responsible to
    develop and administer Quality reporting Metrics/ system for the Management.
  • Align Corporate
    and Site Quality Management System in ensuring consistency of Quality Management System.
  • Support and maintain the local/regional Quality Management
    System(s) (policies, procedures,
    work instructions), with
    revisions and implementations of new 
    regional policies and
    processes.
  • Responsible to initiate Manufacturing Quality Systems on Equipment, Processes, Calibrations, data maintenance/
    abstraction systems, CAPA, Change Control, Risk Management,  etc.
  • Familiar to initiate, prepare and Manage Manufacturing
    Training Systems for Quality
    Management and Audits.
  • Responsible to provide excellent leadership and people
    management skills to internal resources
    in ensuring high productivity.   

      Job Requirements

  •  Minimum Degree in Engineering, Pharmacist or related with at least
    10 to 15 years of working experience in Senior/ Managerial roles.
  • Proven record to effectively lead a group of Managers/ Engineers
    to achieve company goals. 
  • Candidate must be from Medical Devices/
    Pharmaceutical
    Manufacturing environment or related
  • Candidates with the experience of manufacturing process transfers, NPI,
    plant to plant, plant to suppliers and suppliers to plant.
  • We look for candidates with Multinational working experience for a
    global company having global and local Quality Management organizational
    structure.
  • Candidates must be hands-on and knowledgeable with worldwide key regulatory control for Medical Devices requirements for ISO
    13485, TUV, FDA, CI, GMP
    from the initial stage of registration, application, approval,
    administering, audit and maintenance.
  • Proven track records with strong problem solving, communication and
    people skills with stakeholders of different functionalities.
  • Candidates with Lean, Six Sigma certifications will be an added
    advantage and sought after.
  • A self-starter, resourceful with an excellent project management and communication skills.

Country

Malaysia

Contact Email

lina@idealseed.com

Company Info

Medical Equipment manufacturer

Salary

RM 20, 000