Reporting to the Director of Operations the Quality Manager will have responsibility and accountability for Cyden’s Quality Management Systems (QMS).
The successful candidate will have accountability and management of the QMS, ensuring implementation of:-
- Control processes and quality standards; and
- Internal and external procedures assuring product quality, continual improvement, and customer satisfaction
- Management Review process.
Management of the Quality Department, ensuring the team meets corporate and personal objectives, performs all duties as required and are developed in line with business needs
- Ensure that quality is delivered within the manufacturing environment by developing appropriate processes and metrics with the Operations and Engineering teams
- Develop and maintain a process to ensure compliance with national and internal standards and regulations where applicable e.g. US-FDA, China MDR, EU MDR, Health Canada, Korean MFDS, Russia
- Lead for managing all aspects of customer complaints and returns
- Lead contact for dealing with customers and auditors to satisfy individual and regulatory requirements, including corrective actions where applicable.
- Ensure that Cyden QMS document control registration and distribution process satisfy applicable regulatory requirements
- Ensure that Cyden conduct an effective internal audit system to verify that the processes carried out comply with the QMS, Good Manufacturing Process and applicable regulatory requirements.
- Lead Cyden’s inspection and test activities so that only compliant products are delivered to the marketplace via a formal shipping release process.
- Implement supplier evaluations, reviews and monitoring and undertake goods inwards checks on certificates of conformance for critical componentry.
- Ensure that all non-confirming product is segregated and quarantined pending investigation by applicable supplier vendor claim reports, CAPA’s or process records.
- Manage annual development Discussions for Team ensuring that personal objective are agreed and aligned with the Corporate quality objectives.
You should be an experienced Quality professional used to working at senior level with a large manufacturing organisation. Experience of working with medical devices would be particularly beneficial. You must be fully conversant with ISO9001 and MDSAP (ISO13485) and GMP. Questioning by nature, you won’t just accept the status quo, but be driven by continuous improvement and a desire to meet the needs of our customers and regulatory bodies.
You will ideally hold a degree in a relevant subject with excellent MS Office skills and used to working with SAP. Excellent communication skills are essential and you must be able to motivate and coach others in qualify processes
To Apply please send your CV and a covering letter, highlighting your key skills and how you meet the above criteria to: firstname.lastname@example.org, quoting ‘Quality Manager’ in the subject line.