Quality Engineer (Medical Devices)

PE Global is currently recruiting for a Quality Engineer for a leading multi-national medical device client based in Swansea.

This is a full time, permanent position and is 100% based on site in Swansea.

Our client has an exciting opportunity for an experienced Quality Engineer to join them at their Factory site in Swansea, to work closely with the Production team to establish and maintain their quality system for production, packaging, assembly and warehouse activity.

Role:

• Developing and maintaining appropriate quality instructions, specifications and standards;
• Working with purchasing to establish quality requirements for our suppliers, acting as the key contact with suppliers on quality issues and improvements;
• When applicable, undertaking goods inwards checks of Certificates of Conformity and inspection of quality critical components;
• Supporting quality training of production staff and acting as a quality mentor to the production team;
• Undertaking patrol inspections of product quality throughout the assembly and packaging operation;
• Performing audits of the production quality system;
• Recording and investigating non-conformance (product and system);
• Supporting resolution of quality issues, tracking and reporting on progress of corrective and preventive actions;
• Managing the shipping release process for all finished products;
• Managing all aspects of customer returns, including analysis, reporting and progressing corrective actions;
• Ensuring effective control of non-conforming items;
• Maintaining all required records and performance indicators, analysing data to support quality improvement.

Requirements:

Essential

• Experienced in managing quality in a manufacturing environment under a comprehensive quality management system;
• Good understanding of GMP.

Desirable

• Experience of managing quality in an electronic product or medical device assembly operation;
• Working knowledge of ISO 13485.
• Knowledge of APQP, PPAP, Control Plan, FMEA, CAPA, NPI, Validation (IQ, OQ, PQ), MRP, GD&T
• HNC/HND or equivalent in Electrical/Electronic and/or Mechanical Engineering

Other attributes:

• Excellent written and verbal communication skills;
• Excellent accuracy and attention to detail;
• Able to critically evaluate and summarise complex data into simple messages and actions;
• Able to challenge issues in a constructive manner, providing appropriate training and support to improve;
• Organised and methodical;
• Positive and motivated.

Interested candidates should submit an updated CV.

Please click the link below to apply, or alternatively send an up to date CV to Jennifer.horgan@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in UK***