What you need to know

A leading medical device company who manufactures high value injection moulded packaging and components are currently seeking an experienced, committed, and diligent quality professional to join their team.

As a Senior Quality Engineer, you will report directly to the Quality Manager on site and assist the company in achieving its objectives and goals around quality management. The successful candidate will have the opportunity to work with a progressive and innovative quality department, overseeing all aspects of quality in the manufacturing process.

The company have an ambitious growth strategy, are currently extending their cutting-edge manufacturing facility in Co. Longford and are hiring a Senior Quality Engineer due to the continued growth of the business.

This is a permanent role with an excellent salary, package, learning and career development support and genuine opportunities to progress your career.


Your new job

Duties & responsibilities:

• Developing and implementing solutions to sustain and improve the company’s Quality Management System.
• Maintain and help support compliance with ISO 13485 and ISO 14001 systems standards.
• Liaise with customers on new products, quality issues and process qualifications.
• Develop and implement process control programs to ensure customer requirements are met.
• Carry out process validations and qualification on products.
• Provide first class manufacturing support and quality expertise in relation to manufacturing issues and product disposition.
• Performing quality engineering analysis to identify strategies to prevent quality non-conformances and minimise risk.
• Co-ordinate NCR / CAPA processes to ensure timely resolution and closure of issues.
• Lead training activities on Quality Procedures, e.g., Compliance, GMP, Audit Prep and GDP.
• Supporting and representing the site during external audits and carrying out internal audits.
• Analyse trends and track the quality of data to support quality improvements across the business.
• Supporting Environmental, Health and Safety requirements, training, and regulations.

• Third level qualification in Engineering, Polymer Science, or equivalent experience in a highly regulated manufacturing industry.
• A minimum of four years’ experience as a Quality Assurance Engineer within an Injection moulding or medical manufacturing environment.
• Strong attention to detail and an ability to analyse and evaluate large amounts of data, to make data driven decisions.
• In-depth knowledge of Quality Management Systems and ISO standards, specifically, ISO 13485 and ISO 14001.
• Experience in statistical analysis (Minitab) / SPC / validations.
• Excellent interpersonal, communication (written and oral), influencing, and facilitation skills.
• A team player who can work well with cross-functional teams to achieve collect business objectives.
• Strong planning and organisations skills and the ability to prioritise tasks in a fast-paced and dynamic environment.
• Experience in actively participating and taking a leading role in internal and external audits.
• A passion for continuous improvement and a previous track record of improving quality management systems.
• An innovative thinker who is agile and can provide innovative solutions to challenges.
• Experience of guiding and supporting the development of junior members of staff.
   

Interested in this role?

Apply for this job now by sending in a Word version of your CV or get in touch with Oliver at oliver@matrixrecruitment.ie

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