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

📌 Production Operator (India)
🏢 ASTAM DIAGNOSTICS
📍 India