R.T. Lane Recruitment
Initial 12-month contract role.
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. Reporting to the Quality Manager. Providing key support to operations – manufacturing leads / laboratory technicians / facilities leads / calibration / engineering etc.
Main areas of responsibility:
- 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.
- 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
- Identify and lead cost and technical improvements under the departments’ continuous improvement program.
- 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.
- Handles complex technical issues for manufacturing processes that are to be transferred to satellite facilities.
- 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.
- 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
- Support the implementation of all engineering and plant strategic initiatives.
- Leads and executes upgrades to Quality System.
- Actively interfacing with cross-functional team members, always practicing good team-work in support of day to day operating requirements.
- Ensure effective closure on Quality System documents (Audit Actions, NCR’s, CAPA’s, Maps, etc).
- Work with team leader to develop and implement strategic engineering Goals & Objectives.
- 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.
- Maintains and develops risk management lifecycle.
- Responsibility for disposition of non-conforming product, conducting root cause analysis.
Education and Experience Required for Role
- Level 8 degree Qualified in Science/Engineering
- 3yrs relevant experience working in manufacturing/operations.
- It is a requirement to have experience in NC/CAPA.
- Must have experience in a highly regulated/automated industry.
- Ability to do trend analysis and control charts.
- Excellent IT skill e.g., experience in Minitab, excel reports.
- Excellent working knowledge of process excellence / QE tools such as pFMEA, SE statistical analysis, SPC.