Cleanroom Quality Engineer

Custom Interconnect Limited; Andover; Hybrid; GBP 42,000 - 62,000; Full time

Job summary

Custom Interconnect Limited seeks a Quality Engineer (cleanroom) to strengthen the Business Management System and promote a strong quality culture across departments in a manufacturing environment.

You will lead product quality investigations, maintain QMS documents, and support ISO/AS standards, 6S, and continuous improvement initiatives within a compliant cleanroom setting.

Qualifications

• Experience as a Quality Engineer in a manufacturing/engineering setting.
• Experience with ISO 9001, AS9100, ISO 13485 and related accreditations.
• Lean Six Sigma knowledge or certification is desirable.

Responsibilities

• Assist maintenance and development of the Quality Management System (QMS).
• Lead containment, investigations, corrective actions and validations.
• Support cleanroom accreditations and audits (ISO7 BS EN ISO 14644).
• Develop and monitor PFMEAs and quality manufacturing plans.
• Support continuous improvement initiatives and customer-led quality programs.

Skills

Quality engineering

Problem solving

Communication

Microsoft Office

Education

HNC Level 4 in Electronics Engineering

Tools

Microsoft Office

Job description

Contract:

Permanent

Hours:

Monday - Thursday: 08:30 – 17:00

Friday: 08:30 – 15:30

PURPOSE OF ROLE

As Quality Engineer (cleanroom), you will support the development and maintenance of Custom Interconnect Limited’s (CIL) Business Management System by promoting and developing a positive Quality culture within the organisation. More specifically;

• Supporting all other departments to ensure they remain compliant to the accreditations strategic to CIL. Primarily, the AS9100, ISO 9001, ISO 13485 (Medical Devices) and ISO7 cleanroom accreditations for the Company and such other schemes or programs which arise through Customer or market needs of the business such as ISO14001.
• Leading product quality in both customer and production related areas, which would include containment, investigation, correction, implementation, and validation of corrective actions.
• Assisting in the development of a Continuous Improvement culture throughout the Business.
• Supporting the introduction of Customer led Quality Initiatives such as Total Preventative Maintenance.

Key accountabilities include but are not limited to;

• To assist with the maintenance and development of CIL’s Quality Management Systems through the following activities:
• Assist the Process Engineering team to identify and document all clean room-related procedures, SOPs and assembly instructions and review for compliance with accredited Quality Standards.
• Developing, maintaining, monitoring, and reviewing Quality Manufacturing Plans and PFMEAs for key products.
• Supporting the production department to ensure all control measures are followed (material expiration, training records, preventative maintenance, etc.)
• Conducting Quality spot-checks within the production department, such as:
  • Internal spot/scheduled audit of a process or team.
  • Direct inspection of work-in-progress or completed assemblies.
• Assist Senior Management, Process Engineering and Maintenance to monitor clean room performance, monitor personnel adherence to clean room best practices, arrange and coordinate with suppliers for annual deep-clean activity and external validation of clean room performance.
• Function as the first point of contact for all external audits including certification of the clean room to ISO7 standard in accordance with BS EN ISO 14644.
• Establish a clean room specific calibration controls and monitor the status of all measurement equipment used within the clean room, arranging on-site calibration or items to be sent away to an external calibration house.
• Monitor and record the performance of all temperature critical appliances in accordance with CIL procedures.
• Establish a clean room specific tool register to actively monitor and periodically check all bespoke jigs and fixtures in production use, highlighting where tools need to be repaired or replaced.
• To ensure all applicable substances in use within the clean room are suitably identified and present on the company COSHH register, with both TDS and MSDS documents available for review as required.
• Review internal rejections raised by the Production team and lead investigations into cases of repeated poor product quality. Work with and assist Production and Process Engineering to identify and implement opportunities for improvement.
• Review and monitor the accuracy of the training status of all personnel as recorded in the clean room Training Matrix, assisting Production and Process Engineering to highlight additional or improved training needs.
• Assist Production and Process Engineering in the continual monitoring and improvement of application of 6S principles.
• Monitor SPC data alongside engineers applying six sigma methodology to trend analysis.

For the full job description and person specification see here .

Qualifications

• A minimum of 2 years’ experience working in a Quality Engineer role within a manufacturing/engineering environment, prior cleanroom experience is desirable.
• Experience of working within an organisation certified to one or more of the following standards: ISO 9001, AS 9100, ISO 13485, IATF 16949.
• Experience in problem solving and investigation tools such as 8D, CAPA, 5-Whys.
• Experience in internal auditing to ISO 9001, AS9100D or ISO 13485.
• Proficiency in Microsoft Office (or equivalent), data handling and analysis.
• Demonstrable ability to communicate with internal and external stakeholders at all levels of the business.
• Ideally educated to HNC level (Level 4) in a discipline beneficial to the Company’s needs, such as Electronics Engineering.
• Lean Six Sigma qualified to yellow or green belt.
• Experience in inspection, including first article inspection.

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