Job Summary:
This is a fantastic opportunity to work in a supportive, collaborative environment with the latest technology and equipment in our state-of-the-art facility.
Key Responsibilities:
* Develop and implement quality systems to ensure compliance with regulatory requirements, including Medical Device Directive 93/42/EEC, Medical Device Directive 2007/47/EC, Medical Device Regulation 2017/745, and FDA Quality System Regulations 21 CFR § 820 & 803.
* Maintain and continuously improve the quality management systems, identifying areas for improvement and implementing corrective actions.
* Coordinate CAPA, Complaints & Temporary Authorization (Deviations) processes to support owners in meeting required timelines.
* Review and approve non-conformance, CAPA, and complaint investigation reports to ensure accurate and timely completion.
* Manage the annual audit schedule and coordinate internal and external audits as required, ensuring that all necessary documentation is complete and up-to-date.
* Track audit actions from initiation to closure, ensuring that all necessary steps are taken to resolve any issues.
* Prepare and present data to management on quality system performance, including monthly quality reports, highlighting areas of strength and opportunities for improvement.
Requirements:
To be successful in this role, you will need:
* Proven experience in quality systems, including implementation, maintenance, and continuous improvement.
* Strong understanding of regulatory requirements, including Medical Device Directive 93/42/EEC, Medical Device Directive 2007/47/EC, Medical Device Regulation 2017/745, and FDA Quality System Regulations 21 CFR § 820 & 803.
* Excellent communication and interpersonal skills, with the ability to work effectively with cross-functional teams.
* Strong analytical and problem-solving skills, with the ability to identify and implement process improvements.
Benefits:
We offer a competitive salary and benefits package, including:
* Generous holiday entitlement
* Flexible working arrangements
* Opportunities for professional development and growth