Macstaff
Quality Engineer
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Leading Quality Engineering & Assurance for SME Medical Device Manufacturer/Distributor
Based in Ledbury/Herefordshire, this medical device manufacturer/distributor offers a unique opportunity to be part of a company that truly values quality and innovation. Known for designing and manufacturing daily living aids used across the UK and internationally, this organisation places quality at the very core of its operations. Working here means contributing to products that make a real difference in people's lives, within a supportive environment that encourages professional growth and excellence.
You Will Like
The Quality Engineer role itself which is a key leadership position where you will:
- Own and continually develop the Quality Management System to international standards such as ISO 13485 and ISO 9001.
- Lead root cause analysis initiatives, driving systematic improvements through tools like 8D and CAPA.
- Manage investigations into non-conforming products, customer complaints, and field returns, ensuring swift and effective resolutions.
- Support the production team with inspection criteria, first-off checks, and work instructions, playing an active part in new product launches.
- Prepare and maintain robust Quality Control plans based on a proactive risk management approach.
- Assist with international regulatory registrations including EUDAMED, FDA, GUDID, and MHRA, supporting compliance at global levels.
- Champion a culture of continuous quality improvement by engaging cross-functional teams.
- Collaborate with the UK Health, Safety and Environment team to ensure compliance with ISO 14001 and internal HSE standards.
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You Will Have
To be successful as a Quality Engineer here, you will have a healthy mix of the following:
- A relevant qualification in Engineering, Quality, or a related discipline.
- Proven experience working within a manufacturing environment, preferably within medical devices or regulated markets.
- Practical knowledge of ISO 9001 and ISO 13485 Quality Management Systems.
- Strong problem-solving skills, with experience in methodologies such as 8D and CAPA.
- Excellent root cause analysis capabilities and the ability to formulate sustainable corrective actions.
- Experienced in internal auditing and comfortable supporting external audits.
- Familiarity with ERP/MRP systems, measuring and calibration equipment.
- Strong analytical skills to compile reports and recommend practical improvements.
- Excellent communication and influencing skills, capable of building relationships across levels.
- Willingness and ability to travel to other sites when required.
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Desirable criteria include internal auditor training, ability to interpret engineering drawings, experience with lean principles, and familiarity with medical device standards.
You Will Get
As a dedicated Quality Engineer, you will enjoy:
- A competitive salary in the range of £38,000 to £43,000 plus benefits.
- Opportunities for professional development within a global organisation.
- Engagement in impactful work that directly impacts quality standards.
- Supportive team environment that values expertise and initiative.
You Can Apply
To this Quality Engineer role by pushing the button on this job posting, or by sending your CV in confidence to anthony@macstaff.co.uk
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