Job description

An established family-owned manufacturing company based in Coleraine, who supply medical devices for respiratory and surgical needs are seeking to recruit for a permanent Qulality Engineer.

Their vision is to be a truly global, people invested, trusted partner for healthcare professionals and people who rely on our innovative solutions, in focused therapeutic areas, to improve outcomes and quality of life

The company's Operations team is located over 3 core sites within N Ireland.

Are you looking for a new challenege within the Quality Engineering and manufacturing arena then this could be the position for you!

Quality Engineer - Reporting to the Quality Manager, this is an exciting opportunity to join a growing team and work closely with various functions.

Working in close partnership with our Research and Development and Manufacturing teams to ensure all quality and regulatory requirements are in place for all new products; Reviewing and improving our systems within the Comber plant implementing change where appropriate and ensuring compliance with the Quality Management System. This role will suit an individual who can quickly build professional working relationships, works well as part of a team and can investigate and implement improvement activities.

Key activities and duties:

Quality processes

• Work with other departments as required to implement, enhance and maintain relevant processes as required by the quality management system.
• Review quality processes and recommend improvements to quality, efficiency and output.
• Carry out audits of relevant processes as per schedule and implement improvements as required.
• Investigate internal and external quality issues and document root cause and corrective actions, liaising with relevant departmental representatives to ensure sustained ongoing adherence to quality system requirements.
• Assist with process and software validation activities, providing guidance to relevant personnel ensuring appropriate protocols and reports are completed.
• Establish / update documented procedures as required and ensure appropriate training is completed.
• Identification, investigation and documentation of product and process non-conformances.
• Input to regular risk management activities including performing product-related risk analysis.

Production support

• Provide regular and ad hoc feedback on quality related issues and work with relevant personnel to ensure compliance and implement improvements.
• Assist with the implementation of product and process changes, ensuring that quality system requirements are maintained.
• Develop and monitor quality metrics and implement improvement activities as required, in collaboration with relevant personnel.

New Product Introduction (NPI)

• Work as part of the NPI team to ensure that quality and regulatory requirements are known, understood and adhered to during the NPI process.
• Support the development of appropriate documents to describe and control quality and regulatory aspects of NPI.

Communication

• Communicate clearly (both in writing and verbally) to all levels on quality related issues.
• Liaise with other functions within the Eakin Healthcare business to develop, implement and maintain company processes and techniques to reflect best practice, in areas including Quality, Health & Safety and Environmental management.

KEY SKILLS - Essential

• A degree / HND or equivalent qualification in an engineering, scientific or related discipline
• Proven experience in a volume manufacturing environment as a Quality Engineer or similar
• Experience of using problem solving and root cause analysis tools (8D, FMEA etc)
• Strong interpersonal and communication skills
• Methodical thinker, capable of making rational judgements from available information and meeting targets in agreed timescales
• Able to quickly build effective professional working relationships

Desirable

• Experience in a medical device / life sciences environment
• Knowledge of standards and regulatory requirements associated with medical devices e.g. ISO13485, ISO14971, MDD, EU MDR, MDSAP
• Experience in use of Minitab or similar statistical analysis software
• Experience in implementing and ensuring timely completion of appropriate Root Cause analysis and Corrective or Preventative Actions arising from product/process/customer complaint/audit issues
• Experience in development of training materials and delivery of training presentations
• Quality auditing certification
• Experience of using lean manufacturing / improvement tools such as 5S, Six Sigma, Kaizen, process mapping

KEY WORKING RELATIONSHIPS

Internal

• R & D - to ensure that quality and regulatory requirements are met during new product introduction projects
• Production - to liaise with production personnel at all levels to ensure requirements for quality are defined and met. Develop, implement and maintain appropriate quality metrics

External

• Dealing with suppliers to discuss quality related issues and improvements * Dealing with customers and third-party auditors during quality audits

Key Competencies:

Resilience - Can work under pressure, remains calm, thinks clearly and manages emotion under pressure. Addresses issues without being aggressive or controlling and can easily bounce back from setbacks. Is open to feedback and doesn't dwell on past events.

Team Working - Enjoys participating in group activities and likes to work in close proximity with other people. Is ready to collaborate with and support others and is willing to co-operate and compromise for the overall good.

Analytical - Enjoys analysing qualitative data but also considers quantitative and seeks to identify and explore the key elements in information before making commitments. Tends to like to use facts and figures when planning and reporting and is concerned about accuracy and detail.

Information Gathering - Enjoys dealing with and refers to factual data. Likes to be well informed and drills down into details. Prefers to access wide range of information and opinion before making decisions and when solving problems.

Planning and Organising - Thinks things through well in advance and maps out future activities, taking the key stages and requirements into account. Likes to monitor to ensure that things are implemented and delivered effectively.

Quality Orientation - Is precise, pays attention to details, checks things and ties up 'loose ends'. Has a strong conscience about getting things right and seeks to ensure that decisions and solutions do not involve undue risk, adheres to policy and standards.

Interpersonal / Influencing - Deals with others in a convincing way that leads to gaining agreement without relying on hierarchy and shows sensitivity to working relationships. Doesn't give up easily in the face of opinions that differ from their own. Influences others to reach conclusions and gain agreements.

If you wish to find out more about this position or similar roles please contact Katrina Marron 028 25 642699 or email katrina.marron@staffline.co.uk