Position: Mid-Senior level

Job type: Full-time

Salary: Negotiate

Loading ...

Job content

Responsibilities

  • Quality Control/Assurance
    • Participate in development and writing of Quality Systems and QA Procedures
    • Ensure compliance to SOPs
    • Participate in Corrective and Preventive Actions Plans
    • Work with regulatory department on technical dossier update and make changes according to Regulatory needs
    • Ensure timely investigation and report for customer complaints
    • Conduct training for incoming, in-process and outgoing control
    • Perform regulatory assessment on changes in system
    • Support compliance, audit, regulatory and training activities
  • Audit / Document Control
    • Work with management to determine audit scope and timelines
    • Plan and perform audits such as operational, internal and compliance audits
    • Review audit findings and develop action plans
    • Participate in audit meetings and coordinate internal and external audit activities
    • Develop corporate policies and procedures according to regulatory requirements
    • Develop process improvements to improve quality and effectiveness of deliverables
    • Interact with management to determine audit requirements
    • Identify areas of improvements and concerns to management
    • Develop clear and complete reports of audit procedures and findings
    • Develop audit presentations to management as needed
    • Review and recommend improvements to business procedures and internal controls
    • Develop risk models to access and mitigate potential risks
    • Maintain audit documentations according to established standards
    • Organize audit trainings for team for skill development
    • Develop standard tools and procedures to improve audit efficiency
  • Regulatory Affairs
    • Ensure the regulation requirements for the company and medical devices produced are met
    • In charge of license maintenance for the company and medical devices
    • Ensure document control works to maintain the traceability of registration documents
    Requirements
    • Degree/Diploma in Life Science or related field
    • Minimum 2 years of quality assurance management experience
    • Must be able to handle ISO 13485 and CE regulatory requirements
    • Compulsory knowledge of HSA regulation and product registration
    • Experience from medical device field is an advantage
    • Experience in managing a section of Inspectors, Technicians and Engineers
    Interested candidates are invited to submit their resumes and expected salary. (In keeping with PDPC’s guidelines, please do not include NRIC in your resume. We reserve the right not to process any applications that do not adhere to these guidelines.)

    We regret that only shortlisted candidates will be notified.
  • Loading ...
    Loading ...

    Contact Information

    Address: CONTRACT STERILIZATION SERVICES PTE LTD Singapore, Singapore

    Deadline: 30-09-2023

    Loading ...
    Loading ...

    SIMILAR JOBS

    Loading ...
    Loading ...