The Role
We are seeking an experienced and proactive Quality Manager to lead our quality assurance and control activities and maintain our Quality Management System (QMS) in accordance with ISO 13485 and 21 CFR 820.
This is a pivotal leadership role within our growing medical device business ensuring ongoing compliance, managing a team of Quality Technicians, and fostering a strong culture of quality across all departments. The Quality Manager will act as the management representative for our ISO 13485:2016 QMS and will liaise with client quality teams to ensure alignment and effective communication on quality standards and regulatory expectations.
Key Responsibilities:
* Maintain and ensure compliance with the QMS with ISO 13485 and 21 CFR 820
* Lead internal and external audits, management reviews, supplier qualification, and CAPA processes.
* Oversee document control, change control, training systems, and non–conformance investigations.
* Act as Management Representative for ISO 13485:2016 compliance and continuous improvement.
* Implement and monitor quality control systems.
* Conduct and oversee product batch reviews and be responsible for release of product.
* Oversee and ensure timely and accurate quality control testing and related reporting.
* Manage a team of Quality Technicians, ensuring appropriate training and development, to deliver QA/QC needs in a timely manner.
* Build and promote a quality–driven culture across the organisation.
* Participating as a member of the management team, ensuring quality is at the forefront of decision making. This will include regular reporting on quality metrics for the management team and Board.
* Liaise with client Quality Managers to align systems and expectations.
* Support clients and internal teams during regulatory inspections and audits.
* Ensure all staff are trained in QMS and regulatory compliance requirements.
Experience Required:
* Extensive experience in quality assurance within the medical devices industry (ideally 10 years plus)
* Hands–on experience in quality control, including validation and quality method development.
* Proven leadership experience in managing and developing quality teams.
* Track record of successful quality audit preparation and support.
* Familiarity with ISO 13485, FDA 21 CFR Part 820, EU MDR 2017/745, and ISO 14971
* Experience of working in clean room environments is beneficial.
* Experience with eQMS implementation/Document management Systems (desirable)
* Proficiency in Microsoft Excel, Word, and PowerPoint, Outlook
Qualifications:
* Bachelor s degree in engineering, Life Sciences, or a related technical field (desirable)
* ISO 13485:2016 Lead Auditor certification (essential)
* Additional certifications in quality management, risk management, or medical device regulations are a plus.
Please note:Only candidates with the relevant skills and experience will be contacted regarding this position. If you do not hear back from us within 5 days you have unfortunately been unsuccessful in your application for this position, however we may contact you in the future to discuss other opportunities.
Please note: That no terminology in this advert is intended to discriminate on the grounds of a person's gender, marital status, race, religion, colour, age, disability or sexual orientation. Every candidate will be assessed only in accordance with their merits, qualifications and abilities to perform the duties of the job
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