5 FMEA Jobs in India

Finance Director

Location: Gujarat (GIFT City, IFSC)

Key Responsibilities

• Lead the finance, treasury and financial reporting function.
• Manage cash, liquidity and banking relationships.
• Operate within the Delegation of Financial Authority (DoA) framework and support Board-level financial review.
• Manage financial reporting requirements for lenders and equity investors.
• Monitor compliance with financial covenants, conditions and reporting requirements under debt and equity agreements.
• Manage foreign currency requirements, intercompany funding and treasury activities.
• Plan and coordinate equity and debt funding and drawdowns.
• Work with banks and lenders on financing facilities.
• Lead monthly, quarterly and annual financial reporting.
• Manage budgets, forecasts, MIS and Board reporting.
• Ensure compliance with applicable GIFT City / IFSCA and FEMA requirements.
• Coordinate statutory, internal and regulatory audits.
• Support the Board and management on finance, treasury and governance matters.
• Lead the finance function and manage the Tax Manager.
• Act as the main finance contact for the CEO, shareholders, banks, auditors and advisors.

Qualifications & Experience

• CA / CPA / CFA or equivalent qualification; MBA in Finance is an advantage.
• 10–15+ years of post-qualification experience in treasury, corporate finance or financial control.
• Experience with IFSC/GIFT City entities, offshore finance companies, NBFCs, banks or Big 4 advisory is preferred.
• Working knowledge of IFSCA regulations.
• Must meet applicable “Fit and Proper Person” criteria as required by IFSCA.
• Demonstrated experience with cash pooling, ECB/debt structuring and multi-currency treasury operations.
• Strong stakeholder management, people leadership and communication skills appropriate for a Director-level role.
• Willingness to be based in Gandhinagar, GIFT City is required.

Job Title : Medical Device Engineer

Location : Bangalore / Pune

Experience : 5+ Years total, with at least 3 years in Medical Device Development, Sustenance, or DHF Remediation

Notice Period : Immediate to 1 week

Interview Process : L1-selected candidates will undergo a customer interview

Mandatory Skills : Medical Device Development/Sustenance/DHF Remediation, ISO 13485, IEC 60601, ISO 14971, FDA & EU MDR compliance, DHF documentation, Design FMEA, CTS/CTQ, QMS, PLM, Verification & Validation, Impact Assessment.

Key Skills & Knowledge :

• Strong understanding of ISO 13485, IEC 60601, and ISO 14971 standards
• Experience with FDA and EU MDR regulatory requirements

Responsibilities :

• Conduct gap assessments and create/update DHF documents, including user and product requirements, design FMEA, CTS/CTQ, and standards compliance reports
• Analyze and implement design changes, assess impact, and update documentation accordingly
• Identify gaps in verification and validation, ensuring clear traceability between requirements and verification documents
• Assess compliance with applicable standards and regulations
• Define CTS/CTQ parameters and actively participate in design reviews
• Follow QMS guidelines and manage changes through PLM.

Looking for Quality Engineer role for one of our clients for Gurugram Location.

Location: Gurugram

Budget: 10 LPA

Notice: Immediate - 20 Days (Max)

Honors bachelor’s degree in engineering or science fields or equivalency.

Mandatory Skills:

Hands-on experience of PFMEA & Control Plan.

Hands on experience of PPAP, MSA, SPC documentation creation, review and Approval from suppliers.

Hands-on experience of Validation activity – IQ, OQ & PQ

Basic knowledge with GMP, ISO 13485, 21 CFR Part 820 standards

Willing to travel in support of business needs to different geographical locations.

Excellent Communication Skills.

In-depth knowledge in Healthcare and BPaaS domain, Good understanding in Delivery Excellence Framework, Expertise in business and IT processes, platforms, operations, controls and dependencies Secondary Skills: Intermediate to Expert proficiency in conducting audits & assessments in BPaaS domain areas, Proficiency in building, monitoring and testing controls for BPaaS

• Provide facilitation to ensure noiseless delivery and enable best practices adoption & evangelization through appropriate processes and platforms
• Solution consultant for projects to adopt right tools and measure to ensure product & service quality in the appropriate service lines
• Ensure effective governance of projects and deliverables
• Proactive risk management and mitigation, build known risks database to identify and mitigate risks proactively and establish oversight to monitor quality, targets and spending on implementation plan
• Enabling and co-working with the accounts / projects in compliance of regulatory requirements, other certification requirements of the Organization and the Customers for BPaaS domain. Support closure of external/internal audit findings, RCA/CAPA/FMEA for escalations
• Establish Integrated Risk and Delivery Governance models, and oversight to monitor quality, targets, overrun and penalty
• Build process mapping for BPaaS describing the high level activities across Product Service Lines establish ETVX, role definition, gating criteria, SLAs, OLAs and RACI
• Design and ensure operational and compliance controls are implemented, tested and monitored
• Build core competency to carry out DEx BPaaS audits and assessments