Senior Quality & Compliance Manager
Remote (WFH) / London
6 Month Contract
Security Clearance: BPSS
Are you an experienced Senior Quality & Compliance Manager looking for a new contract working on interesting projects?
This is the chance to be involved in an unusual project within the medical sector.
As a Quality & Compliance Specialist, your main responsibilities would be:
- Providing Risk Management technical expertise
- Training and support risk management
- Participating in complaint investigation, including definition of investigation level, root cause analysis, timeliness and quality of response and trending
- Participating in the review and recall of defective product, as necessary
- Facilitating development and completion of risk assessments for field issues/complaints
- Working cross-functionally to use and update risk management files
- Handling of Change Control Requests, Non-Conformities and CAPAs.
- Answering enquiries in the area of quality management, regulations or complaints as the internal competent advisor for all quality-relevant topics
- Supporting the process owners in the creation of guidelines and quality documents
- Assisting in preparation, multi-site collaboration and review of changes to QMS procedures
- Assisting in selection and approval of suppliers/sub-contractor
- Maintaining, updating and communicating key processes, SOPs, policies
- Monitor internal audit non-conformances, perform trend analyses, and present findings
- Extensive Medical devices / IVD experience. (Ideally 10 years or more). IVDD / MDD experience. Pharma or medical background.
- Qualifications / Accreditations – ISO 14971:2012, ISO 62366, ISO 13485:2016, EN 13612:2002
- Quality Assurance, Compliance, Risk Assessment, Document Control, Process Implementation
- Microsoft Office: ppt, Word, Excel, Teams, Good Written English
- Comfortable learning new work platform technologies
- Driven to Deliver and task focussed
- Comfortable working alone and in teams
- Good interpersonal and presentation skills
- Good at mapping processes and developing plans, analysis and reports from scratch, attention to detail, Flexibility
Apply today to be considered for this opportunity. If suitable, you will be contacted to discuss the opportunity with you in detail prior to submitting your CV to the client. In this discussion we will aim to identify your specific skills and motivations, and where appropriate recommend other relevant opportunities to you that match your requirements.
Additionally, refer a friend or colleague to us and receive £200 in vouchers if we assist them in securing a new career.
Keywords: Quality Manager, Medical Devices, Compliance, IVDD, MDD, Senior QA