- Fantastic opporutnity for a graduate to enter the QARA field
- Work with niche medical devices in the orthopedics arena
- Inflential senior leadership team able to mentor and guide
SRG partner with a specialist orthopaedics company, focused on providing strong clinical outcomes to patients and surgeons. Their commitment to quality, professional education development, and service has supported them to achieve exceptional growth since their conception.
As Quality Assurance Specialist, you will report directly to the Quality and Regulatory Manager. With a track record of developing exceptional talent, and promoting within, you will be joining an organisation committed to your personal development both professional development within the medical device arena.
You will support the QARA Manager across maintenance of all QA functions: Internal Audits, Non-Conformances Investigations, CAPA, and Improvement Metrics.
- Manage/conduct document control activities for all quality controlled documents and records
- Ensure SOP's are implemented effectively and followed across the organisation through periodic medical device training and awareness
- Ensure SOPs related to QMS are compliant to ISO13485:2016 by working with relevant departments within the company
- Participate in weekly final batch release activities by reviewing all documents enclosed in DHRs (Device History Records)
- Lead and manage CAPAs raised for the QMS by utilising effective problem solving and root cause analysis tools to drive robust CAPA plans. Implement appropriate corrective actions and verify effectiveness of actions
- Conduct internal audits for all departments within the company and complete audit reports.
- Report on quality metrics to QARA Manager by analysing internal data. Participate in QMS Data Analysis and Trending.
- Manage the audit outcomes and follow through observations with corrective actions. Ensure corrective actions are implemented in a timely manner and manage the closure of audits effectively.
- Risk assessment to ISO 14971 for various QMS processes.
- Mange and conduct Non-Conformance Reports (NCRs) for issues related to audits and QMS controlled processes.
- Conduct training on awareness of Quality Assurance in line with the Quality Policy of the company for all staff or in response to NCRs.
Requirements / Qualifications
- Bachelor's degree in Medical/Mechanical Engineering (or similar).
- Strong technical report writing skills
- Highly diligent and tenacious, able to work with a team and well on own initiative.
Nice to Have
- Experience within the Medical Device or Pharmaceutical Industry supporting Regulated Products
- Practical application experience in continuous improvement methodologies to improve processes, strengthen quality and drive efficiency.
- Internal auditor qualification
- Be able to demonstrate practical knowledge and application of ISO 13485:2016 and associated QA procedures
- Knowledge and understanding of quality standards applicable for this role - ISO 14971, 21 CFR 820, ISO 19011, Medical Device Directive 93/42/EEC and MDR 2017/745 would be beneficial
Please contact me: Holly.Evans@srgtalent.com or +447909 207 693 for a confidential discussion around your career in Regulatory Affairs/Quality Assurance within the Med Tech arena.
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