Production QA OfficerEast Midlands Full Time Attractive salary dependant upon experience Do you have experience working as a QA Officer within a manufacturing/production environment?Have you...
37.5 hours, Mon-Fri
Please contact Andrew to register an interest: 0121 728 8456
My client are a leading manufacturing and innovator of medical devices, and their products offer solutions to life-saving medical care. We are recruiting for a quality officer to assist with their workload and plans going forward.
Scope of role:
Responsible for the compliance activities across all supply chain activities (supplier management, projects, distribution), to meet the requirements of ISO 13485, CFR 820, CMD/CAS, Directive 43/92 EEC, Medical Device requirements. Minimise the risk in the supply chain across all supply categories
- Responsible for co-ordinating Quality activities within Supply Chain to ensure that all quality/compliance issues are addressed and actions implemented to meet the required timescale.
- Manage supplier activities by means of quality assessments and the evaluation and introduction of new suppliers by means of quality assessment and establishing quality expectations
- Drive continuous improvement activities with suppliers to address deficiencies identified in audits and corrective and preventive actions.
- Develop relationships and understanding of OM's requirements with identified key suppliers.
- Drive initiatives with suppliers to deliver measurable performance improvements.
- Develop and manage internal and supplier audit schedules to meet the regulatory requirements.
- Implement the supplier risk management methodology and determine appropriate strategies to mitigate risks for all Quality activities.
- Responsible for the timely implementation of Change
- Controls/CAPA's, Non-Conformities, investigations and Suppliers Qualification.
- Perform supplier audits as required. Perform internal audits as required. Support Customer and Regulatory Audits.
- Produce reports and metrics as required.
Knowledge and Expertise Required:
- Previous auditing experience ideally in med devices, but pharmaceutical/food/biotechnology/chemicals would be considered
- Experience of supplier qualification and/or performance monitoring would be highly advantageous
- Experience of ISO9001/ISO13485, GMP, or similar quality systems
- Ability to confidently liaise with associates of all levels, both written and verbal.
- Experience in manufacturing processes and quality requirements
- Continuous Improvement, problem solving techniques, attention to detail, analytical and methodical approach.
- Highly computer literate e.g. Excel/Word/PowerPoint