Quality Engineer

Job Title: Quality Engineer 

Job Description:

  • Provides support to root cause investigation activities and ensures good Quality Engineering practices are used in investigations. 
  • Drives continuous improvement through data driven approaches and monitoring of quality systems.


− Provides complex product team support for quality system design and audit, compliance assessment, and for support of steady state manufacturing processes.
− Utilizes multifaceted industry and process excellence standards on an expert level in daily quality operations, including good manufacturing practices (GMP), equipment engineering system (EES), and international organization for standardization (ISO).
− Addresses and corrects product and process complaints.
− Reports on contract manufacturer performance metrics and ensures management reviews.
− Oversees audits of all quality system categories to assess compliance to process excellence standards.
− Ensures comprehensive measurement systems to monitor effectiveness of quality and reliability systems to identify, bracket, correct and prevent defects, presenting reports to management.
− Handles complex technical issues for manufacturing processes that are to be transferred to satellite facilities.
− Responsible for supporting the activities of Operations/Engineering/information management in building quality into our products and assuring compliance to the pertinent regulations while at the same time attaining operational effectiveness.
− Leads and executes upgrades to the Quality System.
− Support QA programs in assuring compliance to the pertinent regulation.
− Identify and lead cost and technical improvements under the departments’ continuous improvement program.
− Lead or actively participate in cross-functional teams to ensure New Product.

  • Introduction/Research and Development projects are completed in a timely and efficient manner.
    − Actively interfacing with cross-functional team members, always practicing good teamwork in support of day-to-day operating requirements.
    − Demonstrate strong leadership and a clear identifiable work ethos within the team.
    − Develop and maintain a Credo & Behavioural Standards based culture within the group.
    − Ensure effective closure on Quality System documents (Audit Actions, NCR’s, CAPA’s, Maps, etc).
    − Ensure all process developments, NPI etc are managed in accordance with the Quality management system.
    − Implementation of safety/environmental requirements on purchase of all new equipment.
    − Work with team leader to develop and implement strategic engineering Goals & Objectives.
    − Support the implementation of all engineering and plant strategic initiatives.
    − All employees are responsible for minimising both the Environmental and Health & Safety effects of the work that they perform
    − Maintains and develops risk management lifecycle.
    − Ensuring continuous improvement and understanding of measurement systems used on-site, driving down variance in test methodology.
    − Develops site knowledge on manufacturing process knowledge, and monitors inputs and outputs to the processes, and implements and drives corrective actions.
    − Sustains and advocates Credo based standards in all aspects of work.
    − Supervise others if required.

Education and Experience Required for Role

− Degree Qualified in Science/Engineering.
− Relevant experience working in manufacturing/operations.
− The ability to perform “hands on” troubleshooting and problem solving is required. 

−  The ability to think on the feet and providing sound judgment is highly desired.
− Excellent working knowledge of process excellence / QE tools such as pFMEA, SE, statistical analysis, SPC.
− CAPA and RCI experience.

− Ability to work on own initiative and a part of a team.
− Excellent IT skill e.g., experience in Minitab, excel reports.
− Automated process controls experience.
− Good presentation skills.
− Supervision of others.

Responsibilities and accountabilities will vary for all positions and the scope of individual roles may not be limited to the contents of this position description. QUMAS procedures will define responsibilities from time to time and each manager is responsible for complying with these processes, which supplant any responsibility outlined within. As such, adherence to company procedures is also a responsibility of any roles encompassed within this Job Description.

Quality Engineer

Temp / Perm:  Temp

Service Area: Pharma / Biotech

On Site / Remote: Remote