Head Quality Assurance

6 days ago


Indore, Madhya Pradesh, India Spiceup HR Pvt. Full time ₹ 9,60,000 - ₹ 12,00,000 per year

● Establish, maintain, and continually improve a comprehensive QMS aligned

with ISO 13485, ISO 9001, EU MDR, and USFDA 21 CFR Part 820.

● Lead regulatory, customer, and certification audits with an objective of zero

major non-conformities.

● Ensure compliance across document control, CAPA, deviations, NCRs, OOS,

and risk management.

Leadership & People Development

● Build, mentor, and manage the QA/QC team with focus on discipline,

accuracy, and ownership.

● Foster a culture of quality-first and no-compromise execution.

● Collaborate cross-functionally to ensure alignment between QA, Production,

R&D, and Regulatory Affairs.

Metrics & Continuous Improvement

Define, track, and report quality KPIs:

● Defect rate (PPM)

● OTIF (On-Time In-Full release)

● Yield %, Scrap %, and Line Rejection trends

Drive root cause analysis and corrective actions to minimize recurring issues.

Implement digital tools (LIMS, e-QMS, vision inspection) to enhance quality

control.

What We're Looking For

Education: B.Pharm / M.Sc (Microbiology/Biotech) / BE (Biomedical/Polymer).

Certifications: Lead Auditor – ISO 13485 preferred.

Experience: 10–15 years in QA/QC leadership roles in IVD, medical devices, or

pharma packaging.

Job Types: Full-time, Permanent

Pay: ₹60, ₹100,000.00 per month

Benefits:

  • Paid sick time
  • Paid time off
  • Provident Fund

Work Location: In person


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