Maven Profcon Services LLP
Website:
mavenprofserv.com
Job details:
Key Responsibilities
- Manage and execute QMS implementation, maintenance and AMC activities for clients.
- Review and approve QMS documents, SOPs, Design Files, Validation & Stability Study documents, TCFs, Country Registration Documents and other technical deliverables.
- Conduct and manage Internal Quality Audits (IQA) and Management Review Meetings (MRM).
- Review and manage Audit CARs, NC/OFI closure and corrective actions.
- Plan and monitor AMC activities, Premium AMC plans and annual performance reviews.
- Manage client communication, meetings, site visits and resolution of client queries.
- Allocate and monitor projects/tasks and guide junior team members and interns.
- Conduct and deliver client induction, mock and on-the-job training.
- Monitor competency, KPIs, project progress and departmental performance.
- Identify opportunities for process improvement and automation activities
- Conduct technical interviews and support competency development within the team.
What We’re Looking For
- Bachelor's/Master's degree in Biomedical Engineering, Biotechnology, Life Sciences, Pharmacy, Regulatory Affairs, Quality Management or a relevant field.
- 3+ years of relevant experience in QA/QMS, medical device regulatory affairs, AMC or regulatory consulting.
- Strong knowledge of ISO 13485, QMS, Internal Audits, CAPA/NC management and MRM.
- Strong technical documentation, review and analytical skills.
- Excellent client communication and team-management abilities.
- Ability to independently manage multiple projects and deliverables.
- Experience in medical device consultancy is mandatory.
📍 Location: Ahmedabad
If you are looking for an opportunity to take ownership of QA, AMC, client projects and team responsibilities within the medical device regulatory domain, we would like to hear from you.
Click on Apply to know more.