PRODUCTION MANAGER – IVD MANUFACTURING
Manufacturing & Operations | Full-time | Reports to: VP Operations | Experience: 3–6 years
About the Role
We are looking for a driven Production Manager to lead manufacturing operations at our IVD facility. You will own the end-to-end production cycle — from raw material readiness to finished goods dispatch — while ensuring regulatory compliance, yield targets, and continuous improvement.
IVD domain experience is a plus, not a prerequisite. A strong Six Sigma / Lean background and proven production leadership are what matter most.
Key Responsibilities1. Production Planning
- Drive daily, weekly, and monthly production schedules aligned to dispatch targets
- Manage batch release timelines and capacity planning across product lines
- Coordinate with procurement to ensure uninterrupted material availability
2. Quality & Compliance
- Ensure full compliance with GMP, ISO 13485, CDSCO, and applicable FDA guidelines
- Own CAPA actions and deviation management through to effective closure
- Support and lead preparations for internal and external regulatory audits
3. Lean / Six Sigma & Continuous Improvement
- Lead DMAIC projects targeting improvements in yield, OEE, and scrap reduction
- Implement and sustain 5S, Kaizen, and visual management systems on the shop floor
- Mentor line supervisors and operators on CI tools and problem-solving methodologies
4. Team Leadership
- Lead a cross-functional team of 40–80 operators, technicians, and line supervisors
- Set individual and team KPIs; conduct structured performance reviews
- Build a culture of safety, accountability, quality, and operational discipline
5. Cost & Reporting
- Own the production budget and cost-per-unit targets
- Report OEE, first-time yield, downtime metrics, and COGS insights to senior leadership
- Identify and execute cost-reduction and efficiency improvement initiatives
6. Cross-functional Collaboration
- Partner closely with R&D during new product introduction (NPI) and technology transfer
- Liaise with QA, supply chain, and regulatory affairs on day-to-day operations
- Support equipment and process validation activities (IQ / OQ / PQ)
Qualifications
Must Have
Good to Have
- B.E. / B.Tech or M.Sc. in relevant engineering or science field
- Prior IVD, medical device, or pharmaceutical manufacturing background
- 3+ years in a manufacturing / production leadership role
- ISO 13485 internal auditor certification
- Six Sigma Green Belt minimum (Black Belt strongly preferred)
- Familiarity with CDSCO / CE marking / FDA 510(k) submissions
- Hands-on experience in a GMP-regulated production environment
- New product introduction or tech transfer project experience
- Proficiency in ERP systems (SAP, Oracle, or equivalent)
- Exposure to automation or Industry 4.0 / MES platforms
- Proven people management experience (40+ headcount)
Key Performance Indicators
KPI
Target
Frequency
Production schedule adherence
≥ 95%
Monthly
First-time yield (FTY)
≥ 90%
Monthly
Overall equipment effectiveness (OEE)
≥ 85%
Monthly
Critical audit findings
Zero
Per audit cycle
CAPA closure on time
100%
Rolling
Safety incident closure
100%
Rolling
What We Offer
- Competitive CTC with performance-linked annual bonus
- Group health and personal accident insurance coverage
- Structured learning & development with Six Sigma advancement support
- Fast-track leadership trajectory in a high-growth MedTech environment
- Collaborative, cross-functional work culture with direct leadership access
Pay: ₹25,000.00 - ₹35,000.00 per month
Work Location: In person
