Business Quality Engineer EMEA

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Job Description

The Johnson&Johnson Family of Companies makes a big difference in the health and well-being of people every day. We have more than 250 operating companies in 57 countries employing approximately 114,000 people. Our consumer products and medical devices and diagnostics impact the state of health care for patients, doctors, and nurses around the world. Currently for our Medical Device, we are looking for highly motivated candidate for the position of:

Business Quality Engineer EMEA

Primary Location: Warsaw, Poland

Other Locations: EMEA Emerging Markets


As Business Quality Engineer YOU will:

Be collaborating across multiple functional areas and working closely with a highly dedicated and motivated team. Supporting Johnson & Johnson Vision (JJV) EMEA Marketing companies across Europe with compliance, risk management activities and internal/external audits.

YOUR responsibilities & YOUR impact:
  • Participate as a member of the QA team to drive activities compliance with Johnson & Johnson Quality Policy requirements.
  • Support QMS Risk Management activities within the J&J Vision EMEA Marketing Companies.
  • Provide mentorship on format / content of any required local procedures and 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 host Internal Quality Audits according to schedule.
  • Ensure Quality Issues (NCs, CAPAs) are appropriately documented, monitored and associated metrics are accurately reported.
  • Ensure appropriate application and compliance of site systems with franchise policies and procedures.
  • Support Quality improvement projects
  • Put required Quality Agreements in place (both internal & external)
  • Amount of traveling: 30%

We would love to hear from YOU, if you have:
  • Previous experience in a Quality / Regulatory Role is essential.
  • Your experience includes 1+ year in Quality Engineering Role within a Medical Device or other GMP controlled environment.
  • It is preferred that the job holder holds a further qualification in an Engineering/Science/Technical discipline.
  • Candidates with a background / experience of, internal auditing or hold a certificate as a lead auditor will be looked on favorably.
  • This role demands regular liaison with all relevant marketing companies and their management teams, in addition to close collaborate with both Global and Regional Quality functions.
  • There will be some frequency of work with Regulatory Affairs, Healthcare Compliance and Professional Affairs groups
In return, we offer:
  • 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 employees benefits.

Primary Location
Johnson & Johnson (Poland) Sp. z.o.o. (7815)
Job Function
Requisition ID