Commercial Quality Engineer - EMEA, Johnson & Johnson, Dubai, UAE

 Commercial Quality Engineering will provide support to multiple regional (EMEA) Emerging Markets Vision Care & Surgical Vision Marketing Companies.

The EMEA Regional and Global Commercial Quality groups provide support and guidance to all relevant Marketing Companies in the design of, and subsequent compliance with applicable Quality Systems and processes.

We would consider candidates from all EMEA region

The responsibilities & the impact YOU will have:

  • Participate as a member of the QA team to drive activities of the JJV EMEA Marketing Companies compliance with J&J Quality Policy (TV-QPOL-00001) requirements and Emerging Regulations
  • Support QMS Risk Management activities within the JJV EMEA Marketing Companies. Provide guidance on format / content of any required local procedures. Advise on local facility /process/ documentation requirements as appropriate
  • Provide continuous re-enforcement and training of the respective requirements for medical device regulations and standards and J&J requirements to associates on site, including management. Support the business (line managers) creating training matrices for employees based on their job.
  • Provide technical support as required to JJV EMEA Marketing Companies and execute internal Quality Audits of the JJV EMEA Marketing Companies according to schedule. Ensure CAPA’s within the JJV EMEA Marketing Companies are appropriately documented, monitored and associated metrics are accurately reported. Tracking of quality metric information and reports at the JJV EMEA Marketing Companies. Ensure regional level trend analysis and management review of quality metric information. Prepare the JJV EMEA Marketing Companies for JJRC Audits, help them, during the audits and support any JJRC Audit observation corrective actions and remediation.
  • Provide advice on quality related issues. When necessary, escalate quality / compliance issues per Vision procedures.
  • Ensure appropriate application and compliance of site systems with franchise policies and procedures.
  • Support Quality improvement projects within the JJV EMEA Marketing Companies. Work with JJV EMEA Marketing Companies to ensure any value-added services are controlled appropriately
  • Conduct supplier/Distributor assessments / audits as required. Put required Supplier /Distributor Agreements and compliance in place (both internal & external). Supplier/Distributor quality performance management. Supplier evaluation.
  • Participate to Industry Association / Working Groups where present, to anticipate, analyse current/emerging regulations/trends that impact Quality System as appropriate.

Qualifications

We would love to hear from YOU, if you have:

  • Previous experience in a Quality / Regulatory Role is essential.
  • It is preferred that this experience includes 2+ year in Quality Engineering Role within a Medical Device or other GMP controlled environment.
  • It is preferred to hold a further qualification in an Engineering/Science/Technical discipline.
  • It is preferred that the job holder is an experienced internal auditor or certified lead auditor.
  • The job holder is expected to be capable of planning their daily workload with minimal input.
  • This role demands regular liaison with all relevant marketing companies and their management teams, in addition to close interface with both Global and Regional Quality functions.
  • Frequent interface with Regulatory Affairs, Healthcare Compliance and Professional and Medical Affairs groups.
  • The Job Holder will have the necessary independence, authority and responsibility to initiate action to prevent nonconformities, enact remediation plans, identify and document quality problems, initiate, recommend, provide and verify solutions to quality problems and direct or control further processing and delivery of nonconforming product.
  • Ensuring consistent application of relevant internal standards and processes across the business without compromising customer expectations.
  • The ability to influence without direct authority is essential to success in this role. The job holder must be able to clearly present expectations to all levels of the business, and hold them accountable for meeting these expectations.

This is what awaits YOU at J&J:

  • An opportunity to be part of a global market leader.
  • A dynamic and inspiring working environment.
  • Many opportunities to work on challenging projects and assignments.
  • Possibilities for further personal as well as professional development.
  • Many employee benefits.

 

Employee benefits are regulated by an internal policy that contains full details regarding the entitlement and conditions for the benefits.

 

https://jobs.jnj.com/jobs/2206021522W?lang=en-us&src=JB-10281


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