Reporting to the Quality & Regulatory Affairs Manager, the Quality Systems Engineer will have responsibility for the management and effectiveness of the Quality Process, including reporting and communication. This position will provide Quality Support to Manufacturing in the areas of Process Control, Metrology, Product Quality, Procedural and System Audits, Document Change/ Control, Random Inspections and Training. The Quality Systems Engineer will develop and implement continuous improvement initiatives and preventive measures to achieve quality targets.
- Ensures Quality Systems are implemented and continuously reviewed to ensure compliance with ISO9001 and ISO13485 Quality Management System.
- Manage and participate in the internal QMS Audit process- ensure issues arising are communicated and action taken as appropriate.
- Participate and interface in external audits (Customer, Corporate & Regulatory).
- Liaise directly with external auditors, customers and corporate on matters concerning quality and corrective preventive action activities arising from product/ system non-compliance.
- Develop collaborative relationships with all internal and external stakeholders and share best practices.
- Supplier approval, auditing and performance monitoring.
- Quality and GMP Training.
- QMS Documentation Control /Record Keeping.
- Prepare inputs for Management review.
- Drive quality improvement programmes to achieve performance targets in areas such as audit compliance, reduced complaint levels, NCR and CAPAs, and recommend enhancements to existing practices, equipment or processes to achieve required quality.
- Initiate product hold /containment actions, including completion of non-conforming reports, quarantine notice and any associated rework instruction.
- Review & approval of process and equipment validation/ qualification.
- Establish and support development of quality assurance strategies, processes, guidelines and control plans which assure quality and reliability of manufactured products.
- Ensure risk management activities across the site are actively maintained and mitigated.
- Support the Quality & Regulatory Affairs Manager in meeting the relevant regulatory requirements. Act as customer interface as required.
- Perform miscellaneous duties as assigned by the Quality & Regulatory Affairs Manager.
- Degree in a Quality, Science or Engineering discipline.
- Minimum of 2 years relevant experience in a Quality role essential, preferably in the Medical Device.
- Strong knowledge and application of quality system regulations and ISO standards, and able to support an environment that meets the quality goals of the company.
- ISO13485 Lead Auditor Training supported by practical hands-on experience in QMS auditing.
- Ability to manage multiple concurrent projects or activities, and able to prioritise effectively.
- Excellent verbal & written communication skills, which include but are not limited to presentation, organisational and management skills.
- Knowledge of the Six Sigma approach and methodology for eliminating defects in the manufacturing process is desirable.
- Excellent attention to detail, problem solving skills and ability to communicate effectively.
- Good knowledge of MS Office
Or call Megan Warr on 091507515 for a confidential conversation