Quality Systems Engineer
Posted on Sep 30, 2020 by Real Staffing Group
Job title: Quality Systems Engineer
Benefits: Excellent career development, salary, healthcare and pension.
Reporting to the Quality & Regulatory Affairs Manager, the Quality Systems Engineer will have responsibility for the overall management and effectiveness of the Quality Process. 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.
My client based in Finisklin business park are a single-source solutions provider to the medical device and pharmaceutical sector. Specialising in the design, manufacture, and validation of multi-cavity injection moulds for high volume applications and complex injection-moulded thermoplastic and silicone solutions.
- 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
- Liaise directly with external auditors, customers and corporate on matters concerning quality and corrective preventive action activities arising from product/system noncompliance.
- Develop collaborative relationships with all internal and external stakeholders and share best practices.
- Supplier approval, auditing and performance monitoring.
- 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.
Degree in a Quality, Science or Engineering discipline.
Minimum of 4 years relevant experience in a Quality role essential, preferably in the Medical Device or Injection Moulding Industry.
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
Are you currently open to exploring new opportunities?
If so let me know and I am happy to discuss this role.
Looking forward to hearing from you.
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | London, United Kingdom | Partnership Number | OC387148 England and Wales