required to lead and support increased scope of compliance and associated changes within EU MDR. Activities will relate to monitoring product performance and completing post market surveillance reviews for commercially released Cardiology products.
The successful candidate will supervise, lead and coach members for the group, within this department. Additionally, this hire will be involved in formulating strategy and leading execution on Quality KPIs for product development process, recertification, post market surveillance, risk management and design control SOPs.
This hire will ensure compliance by interpreting and fulfilling regulatory requirements applicable to the medical device industry, promoting and effecting compliance company SOPs and all relevant regulations.
Work content will include analysing, reducing and managing risks associated with the design, use and manufacture of these products, through providing expertise in product development systems to project teams
Strong technical management, communication and stakeholder management skills are required to:
- Lead interaction with Post Market Teams, R&D, Regulatory Affairs, Clinical, Marketing, Process Development and Manufacturing functions in a project team environment.
- Liaise with corporate and divisional quality systems and regulatory affairs personnel in ensuring compliance to internal and external post market surveillance requirements.
- Monitor the release and updates of quality policies to ensure compliance with Post Market Surveillance needs, including any interferences with Design Control and Risk Management.
- Continually seeks to drive improvements in product and process quality.
- Lead input to design reviews, project design plans, risk management, design verification/validation protocols and reports, for new development projects as well as design/process changes to existing product line with respect to product performance
- Lead Post Market Surveillance and Product Performance requirements to development teams and sustaining engineering activities.
Requirements for MDR Post Marketing Surveillance QA Team Lead
- Bachelor’s Degree in Sciences, Engineering (or associated branch of learning) - level 8.
- 5+ years’ experience in a similar role i.e. Quality MDR / Post Marketing Surveillance / Pharmacovigilance (PV) / Design Assurance / Sustaining Engineering.
- Experience in Medical Device or Pharmaceutical environment in design development, post market, or quality role.
- Proven statistical analysis, trending, complaints management, process improvement experience.
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sec