Quality Engineer- II

Location: Oss, North Brabant Salary: €30 - €31 per annum + competitive
Sector: Engineering Type: contract

Job purpose:

Ensures compliance to external and internal regulations / guidelines (Q/EHS).

Responsible for maintaining & improving Quality Management System within the IPT.

Responsible for guiding internal and external inspections/audits.

Continuously analysing current performance to find and lead improvements

Products/Results Key activities


  • Translates new regulations and corporate requirements (gap analysis) to IPT implementation plans.
  • Support implementation of strategy
  • Acts as 1st contact person to global EHS / GMP organization.


  • Support IPT or COE in developing & performing operational compliance tasks (EHS and cGMP) and improvement projects.
  • Manages overview of (new) compliance improvement projects (global) and new policies and assures timely execution via TIER4 priority setting.

General tasks

  • Monitors actual operational EHS/GMP compliance within IPT/COE and takes action if required (go to Gemba).
  • Ensure working according to guidelines; under take immediate actions to solve issues.
  • Advice IPT lead in case of non-compliances; show courage and candor and act independently and autonomous.
  • Develop and report compliance related KPI's (incl. deviations, incidents / capa's etc.).
  • Maintains overview of all IPT related permits and documents and related


  • Participate in EHS/GMP global improvement / implementation projects
  • Develop improvement proposals by using Lean 6-Sigma tools.
  • Is departmental representative in various meetings as described in EHS

management system and various departmental handbooks.

  • Reviews internal documents as SME.
  • Is change owner for compliance (non-processes) related changes.
  • Responsible for internal recurring GMP / EHS routine meetings, coordination and execution of departmental audits.
  • Support improvement engineers with GMP/EHS knowledge and the implementation.
  • Has a direct link to IPT counterpart and Q/EHS representatives in order to

harmonize the way of working across the IPT's.


  • Prepares and coordinates all necessary activities required for internal (incl.

global) and external compliance inspections/audits.

  • Represents department during inspections.
  • Contributes from compliance point of view to Pre-Approval Inspections.
  • Ensures that observations found during inspections are reported, timely solved (action plans) and closed.
  • Responsible for governance/coordination of internal (IPT) inspection rounds.


  • Ensures that new regulations / guidelines (GMP/EHS) are effectively

communicated and trained to all IPT members.

GMP specific

  • Analyses deviations/observations from inspections / go to gemba

observations etc. and suggest improvements.

  • Local QMS owner
  • Ensure compliance and timely updates of procedures, monitor timelines for drafting, reviewing and authorizing procedures.
  • Ensure procedures are aligned (not conflicting with other procedures) within and outside the IPT/COE (gatekeeper within IPT/COE)
  • Acts as DBO expert within the IPT. Trains DBO authors within the IPT/COE.
  • Owner of the Documentation Responsibility Matrix (approval + authorization).
  • Gives input to Validation Master Plan (VMP) & Validation Summary report (VCR)
  • Author for GMP WI/Manuals

EHS specific

  • Coordinate, perform and ensure actual RIE's in IPT/COE
  • Perform rout cause investigations of small incidents and unsafe situations within IPT/COE
  • Perform risk analysis and TRA's; support line management by high risk work activities.
  • Ensure GMO permits are up-to-date and operate as an expert in the IPT during the application of GMO permits of new processes.
  • Participate in investigation teams in case of major incidents
  • EHS Expert within IPT/COE, safe work procedures, corporate guidelines and regulations
  • Is consulted for changes in processes, equipment and investment projects (EHS assessments).
  • Manages continuous improvement projects from AVP (Afdelings Verbeter


  • Ensures compliance to VMS (Vergunningen Management Systeem)
  • Ensures compliance to Environmental Permit.
  • Acts as a Biosafety coordinator within IPT, working together with the local Biosafety Officer
  • Chair AAM meetings IPT/CoE and support AAM members
  • Author for EHS WI/Manuals


  • Continuous focus on quality and safety compliance
  • Go to Gemba
  • Advices IPT lead
  • Make problems visible & strive for Continuous Improvement
  • Strong advisory skills.
  • Helicopter view over multiple IPTs; link impact of improvements or non-compliance issues to other IPT.
  • Pro-actively identify knowledge gaps and propose additional training to IPT lead and/or employee development officer.
  • Execute and/ or participation outside IPT as:
  • Lead or member of (MPS) improvement projects related to EHS/GMP compliance
  • Participation in audit and inspection (preparation) teams
  • Act as SME during risk analyses like HAZOPs, FMEA, PRIE and root cause analysis



Client and/or regulatory inspectors (EHS/GMP)

EHS experts or consultants (arbodienst)


Global EHS / Quality

Everybody within IPT



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Progressive Recruitment is specialized in recruiting professionals in the sectors IT, Global Energy & Natural Recources, Life Sciences, Supply Chain and Engineering. We can help you find temporary and permanent job opportunities in these industries. For more information, visit or