Posted:16 hours ago|
Platform:
On-site
Full Time
● 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: ₹60,000.00 - ₹100,000.00 per month
Benefits:
Work Location: In person
Spiceup HR Pvt.Ltd.
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