Senior Manager

5 days ago

Bengaluru, Karnataka, India UTSAAH Lab, FSID, Indian Institute of Science (IIsc), Bangalore Full time ₹ 20,00,000 - ₹ 25,00,000 per year

Role & responsibilities

  • Build the QMS end to end to ISO 13485:2016: perform gap analysis, draft SOPs/WIs, deploy training, run Stage 1/2 audits and close nonconformities to achieve certification.
  • Own Design Controls & Documentation: create/maintain SRS, DHF, DMR, Risk Management File (ISO 14971), software lifecycle records (IEC 62304), trace matrices and labelling; ensure change control discipline.
  • Regulatory Strategy & Submissions: chart and execute stepwise pathways CDSCO manufacturing licence & device registration first, then FDA 510(k) and EU MDR CE Mark; prepare technical documentation/dossiers and coordinate with test labs, auditors and notified bodies.
  • Audits, CAPA & Metrics: plan and conduct internal audits, lead CAPA investigations, track effectiveness, and publish quality KPIs (training status, NC/CAPA ageing, doc control health) to leadership.
  • Supplier & Manufacturing Quality: qualify critical suppliers/CMOs; define IQ/OQ/PQ plans; establish incoming/in-process controls, traceability and batch-release evidence.
  • Consumables & Sterilisation Readiness: support packaging validation and sterile barrier qualification (ISO and sterilisation modality alignment (EtO/Gamma) as relevant.
  • Post Market & Vigilance: set up complaint handling, PMS/vigilance procedures and field action workflows aligned with India/US/EU expectations.
  • Enable & Train Teams: interpret standards for engineers, run checklists and docs clinics, and raise the organisation's documentation quality.
  • eQMS / Doc Control: implement pragmatic doc and record control and training record systems with audit trails.

Preferred candidate profile

  • Bachelor's degree in Engineering/Life Sciences (Biomedical/Mechanical/Electronics or related). ISO 13485 internal auditor certification preferred (or willingness to obtain within 6 months).
  • 4+ years of QARA experience on Class II+ medical devices, with hands-on ISO 13485 implementation and participation in at least one CDSCO dossier or a 510(k)/EU MDR Technical File.
  • Working knowledge of ISO 14971, IEC 62304, IEC awareness), IEC usability), ISO 10993, ISO 11607, and Indian MDR 2017; familiarity with UDI concepts and eQMS workflows (doc control, training, CAPA).
  • Excellent technical writing and the ability to translate regulatory language into clear, actionable guidance for engineers.
  • Track record of operating with minimal supervision across multiple concurrent workstreams.

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